Sertraline hydrochloride (Zoloft, Lustral) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It was introduced to the market by Pfizer in 1991. Sertraline is primarily used to treat clinical depression in adult outpatients as well as obsessive-compulsive, panic and social anxiety disorders in both adults and children. Sertraline shares the common side effects and contraindications with other members of SSRI class; however, it does not cause weight gain. Controversy and legal actions have resulted from the suspicion that sertraline, similarly to other antidepressants, may increase the risk of suicide. In 2006 it was the most prescribed antidepressant on the U.S. retail market with 28,060,000 prescriptions.[1]
Additional recommended knowledge
History
The history of sertraline[2][3] goes back to the beginning of 1970s when Pfizer chemist Reinhard Sarges synthesized a norepinephrine reuptake inhibitor tametraline[4] Tametraline's development was soon stopped because of undesired stimulant effects observed in animals. Several years later, biochemist Kenneth Koe and chemist Willard Welch generated and tested derivatives of tametraline in vitro for the serotonin reuptake inhibition. Welch then prepared stereoisomers of the most promising candidate, which were tested in vivo by animal behavioral scientist Albert Weissman. The most active (+)-cis-isomer was taken into further development and eventually became sertraline. During the development, the group had to overcome the initial reluctance of Pfizer bureaucracy to pursue sertraline, as Pfizer was considering licensing an antidepressant candidate from another company.
Sertraline was approved by the Food and Drug Administration (FDA) in 1991 based on the recommendation of the Psychopharmacological Drugs Advisory Committee. The committee achieved a consensus that sertraline is safe and efficient for the treatment of depression. During the discussion, Paul Leber, Director of the FDA Division of the Neuropharmacological Drug Products noted that it was a "tough decision", since the treatment effect on outpatients with depression is "modest to minimal". Other experts emphasized that the drug's effect on inpatients is not different from placebo and criticized poor design of the trials by the drug's manufacturer Pfizer.[5] For example, 40% of the participants dropped out of the trials, significantly decreasing their validity.[6]
Until 2003, sertraline was only approved for use in adults ages 18 and over; that year it was approved by the FDA for use in treating children ages 6 to 17 with extreme obsessive compulsive disorder (OCD). In 2003 the UK Medicines and Healthcare Products Regulatory Agency issued a guidance that SSRIs, except fluoxetine (Prozac) are not suitable for the treatment of depression in minors,[7][8]. However, sertraline still can be used for the treatment of OCD in children and adolescents.[9] In 2005 the FDA, changed the labeling of antidepressants, including sertraline, adding a black box warning pertaining to pediatric suicidality, followed in 2007 by the warning regarding the suicidality in young adults.
The patent for Zoloft brand of sertraline expired in 2006,[10] and the drug is now available in generic form.
Indications
Sertraline has been approved for the following indications: depression, obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), panic disorder (PD)[11] and social phobia/social anxiety disorder.[12]
Depression
The original clinical trials demonstrated only moderate efficacy of sertraline for depression (see History). Nevertheless, later research firmly established sertraline as one of the drugs of choice for the treatment of depression in outpatients. In addition, sertraline is effective for dysthymia[13][14] and comparable to imipramine in that respect.[14] In the treatment of depression accompanied by OCD, sertraline performed significantly better than desipramine (Norpramine) on the measures of both OCD and depression.[15]
Comparison with tricyclic antidepressants
Sertraline has a similar effect on the core depressive symptoms as the tricyclic antidepressants (TCAs); however, it is better tolerated and results in a better quality of life.
For example, similar improvement of depression scores was in comparative studies of sertraline versus clomipramine (Anafranil) [16] and amitriptyline (Elavil).[17][18] At the same time, sertraline resulted in a much lower rate of side effects than amitriptyline (49% vs 72% vs 32% for placebo), particularly dry mouth, somnolence, constipation and increased appetite.[18] However, there were more cases of nausea and sexual dysfunction in the sertraline group.[17][18] Furthermore, sertraline patients showed a greater improvement of the subjective quality of life on such measures as work satisfaction, subjective feeling, perceptions of health and cognitive function.[18]
A large and thorough double-blind study compared sertraline, prescribed for chronic (longer than 2 years) depression or depression with dysthymia, to the "gold standard" of depression treatment TCA imipramine (Tofranil). Sertraline was equivalent to imipramine for both of these indications during the first 12 weeks of the study[19][20][21] and the 16 weeks continuation phase.[22] Only 11% of patients on sertraline suffered severe side effects vs. 24% on imipramine. Constipation, dizziness, tremor, dry mouth, micturition disorder and sweating adverse effects were observed more often with imipramine, and diarrhea and insomnia with sertraline.[20] Sertraline patients also reported significantly better social and physical functioning. Interestingly, the patients who achieved a remission during the trial (30% of the sample) did not differ from the healthy population on the measures of marital, parental, physical and work functioning and were close to normal on social adjustment and other measures of interpersonal functioning.[21]
Comparison with other antidepressants
Comparative clinical trials demonstrated that sertraline's efficacy in depression is similar to moclobemide (Aurorix)[23], nefazodone (Serzone),[24], escitalopram (Lexapro)[25], bupropion (Wellbutrin).[26], citalopram (Celexa), fluvoxamine (Luvox), paroxetine (Paxil) and mirtazapine (Remeron).[27] Remarkably, the patients on sertraline had much higher rate of sexual dysfunction (61% vs 10% for men and 41% vs 7% for women), nausea, diarrhea, somnolence and sweating as well as rate of discontinuation due to the side effects (13% vs 3%) than the patients on bupropion.[26] Meta-analysis by the independent Cochrane Collaboration indicated that sertraline is more effective for the treatment of depression than fluoxetine (Prozac) (probability of response 1.4 times higher) and, possibly, is better tolerated.[28] Three comparative studies of sertraline and venlafaxine (Effexor) have been conducted. In the first study supported by the venlafaxine manufacturer Wyeth[29] and in the second — by the sertraline manufacturer Pfizer,[30] sertraline performed marginally worse on some psychiatric scales and similarly to venlafaxine on others. However, the former study was criticized for the methodology shortcomings.[31] A third study, funded by Pfizer, found no differences between sertraline and venlafaxine.[32]
Depression in elderly
Sertraline used for the treatment of depression in elderly (older than 60) was superior to placebo and comparable to another SSRI fluoxetine, and TCAs amitriptyline, nortriptyline (Pamelor) and imipramine. Sertraline had much lower rate of adverse effects than these TCAs, for the exception of nausea, which occurred more frequently with sertraline. In addition, sertraline appeared to be more effective than fluoxetine or nortriptyline in the older than 70 subgroup.[33] A more recent trial of sertraline vs placebo in elderly showed a statistically significant, that is unlikely to occur by chance, but clinically very modest improvement in depression and no improvement in quality of life.[34] The authors were sharply criticized by Bernard Carroll, a one time chairman of the FDA Psychopharmacological Drugs Advisory Committee,[35] for presenting these results as positive: "The study has all hallmarks of an experimercial, a cost-no-object exercise driven by a corporate sponsor to create a positive publicity for its product in a market niche... Thus does the corporate mandate to put lipstick on the pig prevail over the academic duty to communicate independent analysis of the data."[36]
Obsessive-compulsive disorder
Placebo-controlled studies have demonstrated sertraline to be efficacious for the treatment of OCD in adults and children.[37][38][39][40] It was better tolerated and, based on intention to treat analysis, performed better than the gold standard of OCD treatment clomipramine.[41] Sertraline was also marginally more efficacious than fluoxetine (Prozac).[42] If the patient did not respond to sertraline, increasing the dose to 250-400 mg, that is higher than the maximum recommended, did not bring any additional benefits.[43] The patients who responded to sertraline during a short-term trial sustained their improvement when the treatment continued for a year[44] and longer.[45] At the same time, the prolonged treatment may not be necessary for everyone. In a double-blind study, half of the subjects who had been successfully treated for a year were discontinued from sertraline. The rate of relapse among them was the same as in the control group who continued taking sertraline. The withdrawal syndrome may, at least partially, account for the fact that more subjects in the discontinuation group dropped off from the study due to the side effects and worsening of the OCD symptoms. Overall, the 48% of the discontinuation group who were able to complete the study fared as well as the subjects who continued taking sertraline.[46] CBT alone was superior to sertraline in both adults and children; however, the best results were achieved using combination of these treatments.[47][48]
Premenstrual dysphoric disorder
According to several double-blind studies, sertraline is effective in alleviating the symptoms of PMDD, a severe form of premenstrual syndrome. Significant improvement was observed in 50-60% of sertraline patients vs 20-30% of placebo patients. The improvement began during the first week of treatment, and in addition to mood, irritability, and anxiety it was reflected in better family functioning, social activity and general quality of life. Work functioning and the physical symptoms, such as swelling, bloating and breast tenderness, were less responsive to sertraline.[49][50][51] In spite of the well-known sexual side effects of sertraline, significantly higher improvement of sexual functioning was achieved by the sertraline group as compared to the placebo group.[52] A three-way comparison of sertraline, norepinephrine reuptake inhibitor tricyclic antidepressant desipramine, and placebo demonstrated the superiority of sertraline, while desipramine fared no better than placebo.[53] Taking sertraline during the luteal phase, that is only for 12–14 days before menses, was shown to work as well as the continuous treatment.[54][55][52] Although the luteal phase treatment may be more acceptable to patients, there have been indications that by the end of a three-month period it is less well tolerated than the continuous treatment. The study authors suggested that the continuous treatment may allow the tolerance to side effects of sertraline to develop faster.[52] The most recent 2006 trial findings indicate that the continuous treatment with sub-therapeutic dose of sertraline (25 mg vs usual 50-100 mg) may both afford the best efficacy and minimize the side effects.[56]
Posttraumatic stress disorder
Two double-blind placebo-controlled studies confirmed the efficacy of sertraline for a severe chronic PTSD in civilians, with the mean duration of the illness more than 10 years. Physical or sexual assault was the traumatic event for more than 60% the subjects, and 75% of them were women. Over the 12-week period, 53-60% of the patients treated with sertraline were much or very much improved vs 32-38% for placebo.[57][58] The treatment was continued for another year with some participants from both trials. The condition of the responders further improved; some of the patients who did not respond to the initial 12-week trial slowly improved as well, so that about half of them were classified as responders by the end of the following 24 weeks. The authors note that the medication worked slower for those with more severe symptoms.[59][60] Discontinuation of the successful treatment after six months, resulted in the return of the PTSD symptoms in 52% of the patients vs 16% in those who continued taking sertraline.[61] Longer term treatment has been advocated in such cases.[60]
Three-way (placebo-sertraline-third antidepressant) comparison trials of sertraline for PTSD found it to be better than placebo and equivalent to venlafaxine (Effexor)[62] or citalopram (Celexa)[63], and in a two-way comparison it has the same efficacy as nefazodone (Serzone).[64] Sertraline was not effective for veterans with combat-related PTSD.[65][66]
Other indications
Sertraline can also be used in the treatment of general anxiety disorder,[67] binge eating disorder,[68] and premature ejaculation.[69]
There is also evidence that sertraline may be effective in the treatment of refractory neurocardiogenic syncope in children and adolescents.[70]
A study has shown that sertraline is an effective treatment for impulsive aggressive behavior in personality disordered patients.[71]
It has also been used to treat Tourettes Syndrome.
Adverse effects
According to the manufacturer of Zoloft brand of sertraline Pfizer, sertraline is contraindicated in individuals taking monoamine oxidase inhibitors or pimozide (Orap). The alcohol-containing sertraline concentrate is contraindicated with disulfiram (Antabuse).[72] The prescribing information recommends that the treatment of the elderly and patients with liver impairment "must be approached with caution". Due to the slower elimination of sertraline in these groups, their exposure to sertraline may be as high as three times the average exposure for the same dose.[72]
Among the common adverse effects associated with sertraline and listed in the prescribing information, the effects with the greatest difference from placebo are nausea (25% vs 11% for placebo), ejaculation failure (14% vs 1% for placebo), insomnia (21% vs 11% for placebo), diarrhea (20% vs 10% for placebo), dry mouth (14% vs 8% for placebo), somnolence (13% vs 7% for placebo), dizziness (12% vs 7% for placebo), tremor (8% vs 2% for placebo) and decreased libido (6% vs 1% for placebo).[72] Those that most often resulted in interruption of the treatment were nausea (3%), diarrhea (2%) and insomnia (2%).[72] Sertraline appears to be associated with microscopic colitis, a rare condition of unknown etiology.[73]
Akathisia, that is "inner tension, restlessness, and the inability to stay still", caused by sertraline was observed in 16% of patients in a case series.[74] This and other reports[75][76][77] note that akathisia begins soon after the initiation of treatment or increase of the dose, often, several hours after taking the medication. Akathisia usually disappears within several days after sertraline is stopped or its dose is decreased. In some cases, clinicians confused akathisia with anxiety, and increased the dose of sertraline causing further worsening of the patients' symptoms. The experts note that because of the possible link of akathisia with suicide and the distress it causes to the patient, "it is of vital importance to increase awareness amongst staff and patients of the symptoms this relatively common condition".[78][79]
Over more than six months of sertraline therapy for depression, patients showed an insignificant weight increase of 0.1%.[80] Similarly, a 30 months-long treatment with sertraline for OCD, resulted in a mean weight gain of 1.5% (1 kg).[81] Although the difference did not reach statistical significance, the weight gain was lower for fluoxetine (Prozac) (1%) but higher for citalopram (Celexa), fluvoxamine (Luvox) and paroxetine (Paxil) (2.5%). Only 4.5% of the sertraline group gained a large amount of weight (defined as more than 7% gain). This result compares favorably with placebo, where, according to the literature, 3–6% of patients gained more than 7% of their initial weight. The large weight gain was observed only among female members of the sertraline group; the significance of this finding is unclear because of the small size of the group.[81]
Over a two-week treatment of healthy volunteers, sertraline slightly improved verbal fluency and did not affect word learning, short-term memory, vigilance, flicker fusion time, choice reaction time, memory span, and psychomotor coordination.[82][83] In spite of lower subjective rating, no clinically relevant differences were observed in the objective cognitive performance in a group of people treated for depression with sertraline for 1.5 year as compared to healthy controls.[84]
Birth defects and effects on breast-fed infants
The studies comparing the levels of sertraline and its principal metabolite, desmethylsertraline, in mother's blood to their concentration in umbilical cord blood at delivery indicated that the fetus's exposure to sertraline and its metabolite is approximately a third of the maternal exposure.[85][86] The use of sertraline during the first trimester of pregnancy was associated with the increased odds of the following birth defects: omphalocele—six-fold, septal defects—two-fold, anal atresia and limb reduction defects—four-fold.[87] Concentration of sertraline and desmethylsertraline in the breast milk is highly variable and, on average, is of the same order of magnitude as their concentration in the blood plasma of the mother. As a result, more than half of the breast-fed babies receive less than 2 mg/day of sertraline and desmethylsertraline combined, and in most cases these substances are undetectable in their blood.[88] No changes in the serotonin uptake by the platelets of breast-fed infants were found, as measured by their blood serotonin levels before and after their mothers began sertraline treatment.[89]
Sexual side effects
The observed frequency of the sexual side effects depends greatly on whether they are reported by patients spontaneously, as in the manufacturer's trials, or actively solicited by the physicians. There have been several double-blind studies of the sexual side effects comparing sertraline with placebo or other antidepressants.[90] While nefazodone (Serzone) and bupropion did not have negative effect on sexual functioning, 67% of men on sertraline experienced ejaculation difficulties vs. 18% before the treatment[90] (or 61% vs 0% according to another paper[26]). Similarly, in a group of women who initially had not have difficulties achieving orgasm, 41% acquired this problem during treatment with sertraline.[26] The 40% rate of orgasm dysfunction (vs 9% for placebo) on sertraline was observed in a mixed group in another study.[91] Sexual arousal disorder defined as "inadequate lubrication and swelling for women and erectile difficulties for men" occurred in 12% of sertraline patients as compared with 1% of patients on placebo. At the same time, sexual desire and overall satisfaction with sex stayed the same, as in the beginning of the sertraline treatment, and slightly below the placebo.[91]
Suicidality
The FDA requires all antidepressants, including sertraline, to carry a black box warning stating that antidepressants may increase the risk of suicide in persons younger than 25. This warning is based on statistical analyses conducted by two independent groups of the FDA experts that found a 2-fold increase of the suicidal ideation and behavior in children and adolescents, and 1.5-fold increase of suicidality in the 18–24 age group.[92][93][94]
Suicidality in adults
Suicidal ideation and behavior in clinical trials are rare. For the above analysis, the FDA combined the results of 295 trials of 11 antidepressants for psychiatric indications in order to obtain statistically significant results. Considered separately, sertraline use in adults decreased the odds of suicidality with a marginal statistical significance by 37%[94] or 50%[93] depending of the statistical technique used. The authors of the FDA analysis note that "given the large number of comparisons made in this review, chance is a very plausible explanation for this difference".[93] The more complete data submitted later by the sertraline manufacturer Pfizer indicated increased suicidality.[95] Similarly, the analysis conducted by the UK MHRA found a 50% increase of odds of suicide-related events, not reaching statistical significance, in the patients on sertraline as compared to the ones on placebo. [96][97]
Discontinuation syndrome
-
Abrupt interruption of sertraline may result in withdrawal or discontinuation syndrome. This syndrome occurred in 60% of the sertraline subjects in a blind discontinuation study, as compared to 14% of fluoxetine and 66% of paroxetine subjects.[98] During the 5-8 days of the sertraline discontinuation, the most frequent symptoms reported by more than a quarter of patients were irritability, agitation, dizziness, headache, nervousness, crying, emotional lability, bad dreaming and anger. Approximately one third of the subjects experienced mood worsening to the level generally associated with a major depressive episode.[98]
Mechanism of action
Sertraline is primarily a serotonin reuptake inhibitor (SRI). Therapeutic doses of sertraline (50-200 mg/day) taken by patients for four weeks resulted in 80-90% inhibition of serotonin transporter (SERT) in striatum as measured by positron emission tomography. 9 mg/day was sufficient to inhibit 50% of SERT.[99] Sertraline is also a dopamine reuptake inhibitor with 1% of its SRI potency[100] and sigma-1 receptor agonist with 5% of its SRI potency.[101] Sertraline weakly blocks α1-adrenoreceptors with 1-10% of its SRI potency.[100][102]
Pharmacokinetics
Taken orally, sertraline is absorbed slowly, achieving its maximal concentration in the plasma 4-6 hours after ingestion. 98.5% of sertraline in the blood is bound to the plasma proteins. Its half-life in the body is 13-45 hours and is about 1.5 times longer in women (32 hours) than in men (22 hours), resulting in the proportionally 1.5 higher exposure of women.[103] According to in vitro studies, sertraline is metabolized by several cytochrome 450 isoforms: CYP2D6, CYP2C9, CYP2B6, CYP2C19 and CYP3A4, and it appeared unlikely that inhibition of any single isoform could cause clinically significant changes of the sertraline pharmacokinetics.[104][105] No differences in sertraline pharmacokinetics were observed between people with high and low activity of CYP2D6;[106] however, poor CYP2C19 metabolizers had a 1.5 higher level of sertraline than the normal metabolizers.[107] In vitro data also indicate that the inhibition of CYP2B6 should have even greater effect than the inhibition of CYP2C19, while the contribution CYP2C9 and CYP3A4 to the sertraline metabolism would be minor. These conclusions, though, have not been verified in human studies.[105] Sertraline can be deaminated in vitro by monoamine oxidases; however, this metabolic pathway has never been studied in vivo.[105] The major metabolite of sertraline, desmethylsertraline, is about 50-time weaker serotonin transporter inhibitor than sertraline and its clinical effect is negligible.[102]
Interactions
Sertraline is a moderate inhibitor of CYP2D6 and CYP2B6 in vitro.[108] Accordingly, in human trials it caused an increased blood level of such CYP2D6 substrates as metoprolol (Lopressor, Toprol XL), dextromethorphan (Robitussin Cough Suppressant), desipramine (Norpramin), imipramine (Tofranil) and nortriptyline (Pamelor) and CYP3A4/CYP2D6 substrate haloperidol (Haldol).[109][110][111] This effect was dose-dependent; for example, desipramine co-administration with 50 mg of sertraline resulted in a 20% increase of exposure and with 150 mg of sertraline—in a 70% increase of exposure.[103][112] In a placebo-controlled study, the concomitant administration of sertraline caused a 40% increase of the blood level of methadone, which is primarily metabolized by CYP2B6.[113] Sertraline had a slight inhibitory effect on the metabolism of diazepam (Valium), tolbutamide (Orinase) and warfarin (Coumadin), which are CYP2C9 or CYP2C19 substrates; this effect was not considered to be clinically relevant.[103] As expected from the in vitro data, sertraline did not alter the human metabolism of CYP3A4 substrates erythromycin, alprazolam (Xanax), carbamazepine (Tegretol), clonazepam (Klonopin), and terfenadine (Seldane) as well as CYP1A2 substrate clozapine (Clozaril). Sertraline had no effect on the actions of digoxin (Lanoxin) and atenolol (Tenormin), which are not metabolized in the liver.[103][108][72][114] Case reports suggest that taking sertraline with phenytoin (Dilantin) or zolpidem (Ambien) may induce sertraline metabolism and decrease its efficacy and taking sertraline with lamotrigine (Lamictal) may increase the blood level of lamotrigine via an unknown mechanism. Clinical reports indicate that interaction between sertraline and MAOIs isocarboxazid (Marplan) and tranylcypromine (Parnate) may cause serotonin syndrome. In a placebo-controlled study of co-administration of sertraline with lithium, 35% of the subjects experienced tremors versus 0% with placebo.[103]
Controversy
The brand-name form of sertraline, Zoloft, was advertised to consumers using the following wording: "While the cause is unknown, depression may be related to an imbalance of natural chemicals between nerve cells in the brain. Prescription Zoloft works to correct this imbalance. You just shouldn't have to feel this way anymore." An essay in PLOS Medicine noted that there is no scientific support for the "serotonin imbalance" theory of depression and criticized the sertraline manufacturer Pfizer and manufacturers of other SSRIs for using it. When asked to comment on this apparent breach of federal regulations, the FDA answered that the "reductionist statements" could be used to explain the neurochemistry of depression "to the fraction of the public that functions at no higher than a 6th grade reading level."[115] To the FDA's credit, it reacted promptly with a warning letter when a Zoloft advertisement omitted the information about the risk of suicidality.[116]
In the case of Regina vs Hawkins (an Australian court case from the state of New South Wales), Zoloft was described as an important factor in David Hawkins' murder in 1999 (through strangling) of his wife. Hawkins had been depressed, was prescribed 50 mg of Zoloft a day and on his first day of treatment took 250 mg. He claimed on the night of the murder that he couldn't sleep, was agitated and claimed he had hallucinations during the attack on his wife. Several experts agreed that "Zoloft can cause agitation and a certain amount of disinhibition so that some individuals engage in aggressive or dangerous behaviours without due regard for the consequences and in a manner that is out of character for them" and that the prisoner's behavior was consistent with agitated depression further exacerbated by akathisia and toxic delirium that developed as a result of Zoloft overdose. The court concluded that "it can be seen that the medical evidence strongly supports a conclusion that, but for the effects of the 250 milligrams of Zoloft he had taken, it is wholly unlikely that the prisoner would have committed the crime to which he has pleaded guilty. Furthermore, it is common ground that his having done such an act is quite foreign to his former life history, his personality and psychological make up. It was also wholly inconsistent with his love for his marriage partner of nearly fifty years."[117]
In 2004, a Los Angeles nurse sued Pfizer as a private attorney general "on behalf of all California residents who have been misled about Zoloft", claiming the company covered up side effects.[118] In 2005, the Los Angeles Superior Court dismissed the case and ordered the plaintiff to pay the Pfizer's cost of the suit.[119]
References
- ^ The sertraline prescriptions were calculated as a total of prescriptions for Zoloft and generic Sertraline using data from the charts for generic and brand name drugs, see: Top 200 Generic Drugs by Units in 2006PDF and Top 200 Brand-Name Drugs by Units in 2006PDF Drug Topics (March 5, 2007). Retrieved on January 1, 2008
- ^ The most complete account has been presented in: Mullin R (2006). "ACS Award for Team Innovation". Chemical & Engineering News 84 (5): 45-52.
- ^ A short blurb on the history of sertraline, see: Couzin J (2005). "The brains behind blockbusters". Science 309 (5735): 728. doi:10.1126/science.309.5735.728. PMID 16051786.
- ^ For the structure of tametraline, see: tametraline HCl CP 24441-1 (Pfizer). Retrieved on 2007-07-03.
- ^ FDA (1990). Minutes of the 33rd Meeting of Psychopharmacological Drugs Advisory Committee on November 19, 1990 (PDF). Retrieved on 2007-07-20.
- ^ See also:Fabre LF, Abuzzahab FS, Amin M, Claghorn JL, Mendels J, Petrie WM, Dubé S, Small JG (1995). "Sertraline safety and efficacy in major depression: a double-blind fixed-dose comparison with placebo". Biol. Psychiatry 38 (9): 592-602. doi:10.1016/0006-3223(95)00178-8. PMID 8573661.
- ^ MHRA (2003-12-10). Safety review of antidepressants used by children completed. Retrieved on 2007-07-05.
- ^ Boseley, Sarah. "Drugs for depressed children banned", The Guardian, December 10, 2003. Retrieved on 2007-04-19.
- ^ MHRA. Overview of regulatory status and CSM advice relating to major depressive disorder (MDD) in children and adolescents. Retrieved on 2007-07-05.
- ^ Smith, Aaron (July 17, 2006). Pfizer needs more drugs. CNNMoney.com. Retrieved on 2007-01-27.
- ^ Londborg PD, Wolkow R, Smith WT, DuBoff E, England D, Ferguson J, Rosenthal M, Weise C. (1998). "Sertraline in the treatment of panic disorder. A multi-site, double-blind, placebo-controlled, fixed-dose investigation.". The British Journal of Psychiatry 173: 54-60. PMID 9850204.
- ^ Katzelnick DJ, Kobak KA, Greist JH, Jefferson JW, Mantle JM, Serlin RC. (1995). "Sertraline for social phobia: a double-blind, placebo-controlled crossover study.". The American Journal of Psychiatry 152 (9): 1368-1371. PMID 7653696.
- ^ Ravindran AV, Guelfi JD, Lane RM, Cassano GB (2000). "Treatment of dysthymia with sertraline: a double-blind, placebo-controlled trial in dysthymic patients without major depression". The Journal of clinical psychiatry 61 (11): 821–7. PMID 11105734.
- ^ a b Thase ME, Fava M, Halbreich U, Kocsis JH, Koran L, Davidson J, Rosenbaum J, Harrison W (1996). "A placebo-controlled, randomized clinical trial comparing sertraline and imipramine for the treatment of dysthymia". Arch. Gen. Psychiatry 53 (9): 777–84. PMID 8792754.
- ^ Hoehn-Saric R, Ninan P, Black DW, Stahl S, Greist JH, Lydiard B, McElroy S, Zajecka J, Chapman D, Clary C, Harrison W (2000). "Multicenter double-blind comparison of sertraline and desipramine for concurrent obsessive-compulsive and major depressive disorders". Arch. Gen. Psychiatry 57 (1): 76–82. PMID 10632236.
- ^ Lépine JP, Goger J, Blashko C, Probst C, Moles MF, Kosolowski J, Scharfetter B, Lane RM (2000). "A double-blind study of the efficacy and safety of sertraline and clomipramine in outpatients with severe major depression". International clinical psychopharmacology 15 (5): 263—71. PMID 10993128.
- ^ a b Reimherr FW, Chouinard G, Cohn CK, Cole JO, Itil TM, LaPierre YD, Masco HL, Mendels J (1990). "Antidepressant efficacy of sertraline: a double-blind, placebo- and amitriptyline-controlled, multicenter comparison study in outpatients with major depression". The Journal of clinical psychiatry 51 Suppl B: 18-27. PMID 2258378.
- ^ a b c d Lydiard RB, Stahl SM, Hertzman M, Harrison WM (1997). "A double-blind, placebo-controlled study comparing the effects of sertraline versus amitriptyline in the treatment of major depression". The Journal of clinical psychiatry 58 (11): 484-91. PMID 9413414.
- ^ Rush AJ, Koran LM, Keller MB, Markowitz JC, Harrison WM, Miceli RJ, Fawcett JA, Gelenberg AJ, Hirschfeld RM, Klein DN, Kocsis JH, McCullough JP, Schatzberg AF, Thase ME (1998). "The treatment of chronic depression, part 1: study design and rationale for evaluating the comparative efficacy of sertraline and imipramine as acute, crossover, continuation, and maintenance phase therapies". The Journal of clinical psychiatry 59 (11): 589-97. PMID 9862605.
- ^ a b Keller MB, Gelenberg AJ, Hirschfeld RM, Rush AJ, Thase ME, Kocsis JH, Markowitz JC, Fawcett JA, Koran LM, Klein DN, Russell JM, Kornstein SG, McCullough JP, Davis SM, Harrison WM (1998). "The treatment of chronic depression, part 2: a double-blind, randomized trial of sertraline and imipramine". The Journal of clinical psychiatry 59 (11): 598-607. PMID 9862606.
- ^ a b Miller IW, Keitner GI, Schatzberg AF, Klein DN, Thase ME, Rush AJ, Markowitz JC, Schlager DS, Kornstein SG, Davis SM, Harrison WM, Keller MB (1998). "The treatment of chronic depression, part 3: psychosocial functioning before and after treatment with sertraline or imipramine". The Journal of clinical psychiatry 59 (11): 608-19. PMID 9862607.
- ^ Koran LM, Gelenberg AJ, Kornstein SG, Howland RH, Friedman RA, DeBattista C, Klein D, Kocsis JH, Schatzberg AF, Thase ME, Rush AJ, Hirschfeld RM, LaVange LM, Keller MB (2001). "Sertraline versus imipramine to prevent relapse in chronic depression". Journal of affective disorders 65 (1): 27-36. PMID 11426506.
- ^ Papakostas GI, Fava M (2006). "A metaanalysis of clinical trials comparing moclobemide with selective serotonin reuptake inhibitors for the treatment of major depressive disorder". Canadian journal of psychiatry. Revue canadienne de psychiatrie 51 (12): 783-90. PMID 17168253.
- ^ Feiger A, Kiev A, Shrivastava RK, Wisselink PG, Wilcox CS (1996). "Nefazodone versus sertraline in outpatients with major depression: focus on efficacy, tolerability, and effects on sexual function and satisfaction". The Journal of clinical psychiatry 57 Suppl 2: 53-62. PMID 8626364.
- ^ Ventura D, Armstrong EP, Skrepnek GH, Haim Erder M (2007). "Escitalopram versus sertraline in the treatment of major depressive disorder: a randomized clinical trial". Current medical research and opinion 23 (2): 245-50. doi:10.1185/030079906X167273. PMID 17288677.
- ^ a b c d Kavoussi RJ, Segraves RT, Hughes AR, Ascher JA, Johnston JA (1997). "Double-blind comparison of bupropion sustained release and sertraline in depressed outpatients". The Journal of clinical psychiatry 58 (12): 532-7. PMID 9448656.
- ^ For the review, see:Hansen RA, Gartlehner G, Lohr KN, Gaynes BN, Carey TS (2005). "Efficacy and safety of second-generation antidepressants in the treatment of major depressive disorder". Ann. Intern. Med. 143 (6): 415-26. PMID 16172440.
- ^ Cipriani A, Brambilla P, Furukawa T, Geddes J, Gregis M, Hotopf M, Malvini L, Barbui C (2005). "Fluoxetine versus other types of pharmacotherapy for depression". Cochrane database of systematic reviews (Online) (4): CD004185. doi:10.1002/14651858.CD004185.pub2. PMID 16235353.
- ^ Mehtonen OP, Søgaard J, Roponen P, Behnke K (2000). "Randomized, double-blind comparison of venlafaxine and sertraline in outpatients with major depressive disorder. Venlafaxine 631 Study Group". The Journal of clinical psychiatry 61 (2): 95-100. PMID 10732656.
- ^ Shelton RC, Haman KL, Rapaport MH, Kiev A, Smith WT, Hirschfeld RM, Lydiard RB, Zajecka JM, Dunner DL (2006). "A randomized, double-blind, active-control study of sertraline versus venlafaxine XR in major depressive disorder". The Journal of clinical psychiatry 67 (11): 1674-81. PMID 17196045.
- ^ Wise TN, Sheridan MJ (2000). "Venlafaxine versus sertraline for major depressive disorder". The Journal of clinical psychiatry 61 (11): 873-4. PMID 11105744.
- ^ Sir A, D'Souza RF, Uguz S, George T, Vahip S, Hopwood M, Martin AJ, Lam W, Burt T (2005). "Randomized trial of sertraline versus venlafaxine XR in major depression: efficacy and discontinuation symptoms". The Journal of clinical psychiatry 66 (10): 1312-20. PMID 16259546.
- ^ Muijsers RB, Plosker GL, Noble S (2002). "Sertraline: a review of its use in the management of major depressive disorder in elderly patients". Drugs & aging 19 (5): 377-92. PMID 12093324.
- ^ Schneider LS, Nelson JC, Clary CM, Newhouse P, Krishnan KR, Shiovitz T, Weihs K (2003). "An 8-week multicenter, parallel-group, double-blind, placebo-controlled study of sertraline in elderly outpatients with major depression". The American journal of psychiatry 160 (7): 1277-85. PMID 12832242.
- ^ BERNARD J. CARROLL (html). Retrieved on 2007-08-08.
- ^ Carroll BJ (2004). "Sertraline and the Cheshire cat in geriatric depression". The American journal of psychiatry 161 (4): 759; author reply 759-61. PMID 15056533.
- ^ Kronig MH, Apter J, Asnis G, Bystritsky A, Curtis G, Ferguson J, Landbloom R, Munjack D, Riesenberg R, Robinson D, Roy-Byrne P, Phillips K, Du Pont IJ. (1999). "Placebo-controlled, multicenter study of sertraline treatment for obsessive-compulsive disorder.". Journal of Clinical Psychopharmacology 19 (2): 172-176. PMID 10211919.
- ^ Chouinard G, Goodman W, Greist J, Jenike M, Rasmussen S, White K, Hackett E, Gaffney M, Bick PA (1990). "Results of a double-blind placebo controlled trial of a new serotonin uptake inhibitor, sertraline, in the treatment of obsessive-compulsive disorder". Psychopharmacology bulletin 26 (3): 279–84. PMID 2274626.
- ^ Greist J, Chouinard G, DuBoff E, Halaris A, Kim SW, Koran L, Liebowitz M, Lydiard RB, Rasmussen S, White K (1995). "Double-blind parallel comparison of three dosages of sertraline and placebo in outpatients with obsessive-compulsive disorder". Arch. Gen. Psychiatry 52 (4): 289–95. PMID 7702445.
- ^ Geller DA, Biederman J, Stewart SE, Mullin B, Martin A, Spencer T, Faraone SV (2003). "Which SSRI? A meta-analysis of pharmacotherapy trials in pediatric obsessive-compulsive disorder". The American journal of psychiatry 160 (11): 1919–28. PMID 14594734.
- ^ Flament MF, Bisserbe JC (1997). "Pharmacologic treatment of obsessive-compulsive disorder: comparative studies". The Journal of clinical psychiatry 58 Suppl 12: 18–22. PMID 9393392.
- ^ Bergeron R, Ravindran AV, Chaput Y, Goldner E, Swinson R, van Ameringen MA, Austin C, Hadrava V (2002). "Sertraline and fluoxetine treatment of obsessive-compulsive disorder: results of a double-blind, 6-month treatment study". Journal of clinical psychopharmacology 22 (2): 148–54. PMID 11910259.
- ^ Ninan PT, Koran LM, Kiev A, Davidson JR, Rasmussen SA, Zajecka JM, Robinson DG, Crits-Christoph P, Mandel FS, Austin C (2006). "High-dose sertraline strategy for nonresponders to acute treatment for obsessive-compulsive disorder: a multicenter double-blind trial". The Journal of clinical psychiatry 67 (1): 15–22. PMID 16426083.
- ^ Greist JH, Jefferson JW, Kobak KA, Chouinard G, DuBoff E, Halaris A, Kim SW, Koran L, Liebowtiz MR, Lydiard B (1995). "A 1 year double-blind placebo-controlled fixed dose study of sertraline in the treatment of obsessive-compulsive disorder". International clinical psychopharmacology 10 (2): 57–65. PMID 7673657.
- ^ Rasmussen S, Hackett E, DuBoff E, Greist J, Halaris A, Koran LM, Liebowitz M, Lydiard RB, McElroy S, Mendels J, O'Connor K (1997). "A 2-year study of sertraline in the treatment of obsessive-compulsive disorder". International clinical psychopharmacology 12 (6): 309–16. PMID 9547132.
- ^ Koran LM, Hackett E, Rubin A, Wolkow R, Robinson D (2002). "Efficacy of sertraline in the long-term treatment of obsessive-compulsive disorder". The American journal of psychiatry 159 (1): 88–95. PMID 11772695.
- ^ (2004) "Cognitive-behavior therapy, sertraline, and their combination for children and adolescents with obsessive-compulsive disorder: the Pediatric OCD Treatment Study (POTS) randomized controlled trial". JAMA 292 (16): 1969–76. doi:10.1001/jama.292.16.1969. PMID 15507582.
- ^ Sousa MB, Isolan LR, Oliveira RR, Manfro GG, Cordioli AV (2006). "A randomized clinical trial of cognitive-behavioral group therapy and sertraline in the treatment of obsessive-compulsive disorder". The Journal of clinical psychiatry 67 (7): 1133–9. PMID 16889458.
- ^ Yonkers KA, Halbreich U, Freeman E, Brown C, Endicott J, Frank E, Parry B, Pearlstein T, Severino S, Stout A, Stone A, Harrison W. (1997). "Symptomatic improvement of premenstrual dysphoric disorder with sertraline treatment. A randomized controlled trial. Sertraline Premenstrual Dysphoric Collaborative Study Group.". The Journal of the American Medical Association 278 (12): 983-988. PMID 9307345.
- ^ Review: Pearlstein T (2002). "Selective serotonin reuptake inhibitors for premenstrual dysphoric disorder: the emerging gold standard?". Drugs 62 (13): 1869–85. PMID 12215058.
- ^ Review: Ackermann RT, Williams JW (2002). "Rational treatment choices for non-major depressions in primary care: an evidence-based review". J Gen Intern Med 17 (4): 293–301. PMID 11972726.
- ^ a b c Freeman EW, Rickels K, Sondheimer SJ, Polansky M, Xiao S (2004). "Continuous or intermittent dosing with sertraline for patients with severe premenstrual syndrome or premenstrual dysphoric disorder". Am J Psychiatry 161 (2): 343–51. PMID 14754784.
- ^ Freeman EW, Rickels K, Sondheimer SJ, Polansky M (1999). "Differential response to antidepressants in women with premenstrual syndrome/premenstrual dysphoric disorder: a randomized controlled trial". Arch. Gen. Psychiatry 56 (10): 932–9. PMID 10530636.
- ^ Jermain DM, Preece CK, Sykes RL, Kuehl TJ, Sulak PJ (1999). "Luteal phase sertraline treatment for premenstrual dysphoric disorder. Results of a double-blind, placebo-controlled, crossover study". Arch Fam Med 8 (4): 328–32. PMID 10418540.
- ^ Halbreich U, Bergeron R, Yonkers KA, Freeman E, Stout AL, Cohen L (2002). "Efficacy of intermittent, luteal phase sertraline treatment of premenstrual dysphoric disorder". Obstet Gynecol 100 (6): 1219–29. PMID 12468166.
- ^ Kornstein SG, Pearlstein TB, Fayyad R, Farfel GM, Gillespie JA (2006). "Low-dose sertraline in the treatment of moderate-to-severe premenstrual syndrome: efficacy of 3 dosing strategies". J Clin Psychiatry 67 (10): 1624–32. PMID 17107257.
- ^ Brady K, Pearlstein T, Asnis GM, Baker D, Rothbaum B, Sikes CR, Farfel GM (2000). "Efficacy and safety of sertraline treatment of posttraumatic stress disorder: a randomized controlled trial". JAMA 283 (14): 1837–44. PMID 10770145.
- ^ Davidson JR, Rothbaum BO, van der Kolk BA, Sikes CR, Farfel GM (2001). "Multicenter, double-blind comparison of sertraline and placebo in the treatment of posttraumatic stress disorder". Arch. Gen. Psychiatry 58 (5): 485–92. PMID 11343529.
- ^ Londborg PD, Hegel MT, Goldstein S, Goldstein D, Himmelhoch JM, Maddock R, Patterson WM, Rausch J, Farfel GM (2001). "Sertraline treatment of posttraumatic stress disorder: results of 24 weeks of open-label continuation treatment". The Journal of clinical psychiatry 62 (5): 325–31. PMID 11411812.
- ^ a b Davis LL, Frazier EC, Williford RB, Newell JM (2006). "Long-term pharmacotherapy for post-traumatic stress disorder". CNS drugs 20 (6): 465–76. PMID 16734498.
- ^ Davidson J, Pearlstein T, Londborg P, Brady KT, Rothbaum B, Bell J, Maddock R, Hegel MT, Farfel G (2001). "Efficacy of sertraline in preventing relapse of posttraumatic stress disorder: results of a 28-week double-blind, placebo-controlled study". The American journal of psychiatry 158 (12): 1974–81. PMID 11729012.
- ^ Davidson J, Rothbaum BO, Tucker P, Asnis G, Benattia I, Musgnung JJ (2006). "Venlafaxine extended release in posttraumatic stress disorder: a sertraline- and placebo-controlled study". Journal of clinical psychopharmacology 26 (3): 259–67. doi:10.1097/01.jcp.0000222514.71390.c1. PMID 16702890.
- ^ Tucker P, Potter-Kimball R, Wyatt DB, Parker DE, Burgin C, Jones DE, Masters BK (2003). "Can physiologic assessment and side effects tease out differences in PTSD trials? A double-blind comparison of citalopram, sertraline, and placebo". Psychopharmacology bulletin 37 (3): 135–49. PMID 14608246.
- ^ McRae AL, Brady KT, Mellman TA, Sonne SC, Killeen TK, Timmerman MA, Bayles-Dazet W (2004). "Comparison of nefazodone and sertraline for the treatment of posttraumatic stress disorder". Depression and anxiety 19 (3): 190–6. doi:10.1002/da.20008. PMID 15129422.
- ^ Zohar J, Amital D, Miodownik C, Kotler M, Bleich A, Lane RM, Austin C (2002). "Double-blind placebo-controlled pilot study of sertraline in military veterans with posttraumatic stress disorder". Journal of clinical psychopharmacology 22 (2): 190–5. PMID 11910265.
- ^ Friedman MJ, Marmar CR, Baker DG, Sikes CR, Farfel GM (2007). "Randomized, double-blind comparison of sertraline and placebo for posttraumatic stress disorder in a Department of Veterans Affairs setting". The Journal of clinical psychiatry 68 (5): 711–20. PMID 17503980.
- ^ Allgulander C, Dahl AA, Austin C, Morris PL, Sogaard JA, Fayyad R, Kutcher SP, Clary CM. (2004). "Efficacy of sertraline in a 12-week trial for generalized anxiety disorder.". The American Journal of Psychiatry 161: 1642-1649. PMID 15337655.
- ^ McElroy SL, Casuto LS, Nelson EB, Lake KA, Soutullo CA, Keck PE Jr, Hudson JI. (2000). "Placebo-controlled trial of sertraline in the treatment of binge eating disorder.". The American Journal of Psychiatry 157 (6): 1004-1006. PMID 10831483.
- ^ McMahon CG. (1998). "Treatment of premature ejaculation with sertraline hydrochloride: a single-blind placebo controlled crossover study.". The Journal of Urology 159 (6): 1935-1938. PMID 9598491.
- ^ Grubb BP, Samoil D, Kosinski D, Kip K, Brewster P. (1994). "Use of sertraline hydrochloride in the treatment of refractory neurocardiogenic syncope in children and adolescents.". Journal of the American College of Cardiology 24 (2): 490-494. PMID 8034887.
- ^ Kavoussi RJ, Liu J, Coccaro EF. (1994). "An [[open trial (medical)|]] of sertraline in patients with personality disorder who also have impulsive aggression.". Journal of Clinical Psychiatry 55 (4): 137-141. PMID 8071257.
- ^ a b c d e [www.zoloft.com/ Zoloft Prescribing Information for the U.S.] (PDF). Pfizer. Retrieved on 2007-09-09.
- ^ Fernández-Bañares F, Esteve M, Espinós JC, Rosinach M, Forné M, Salas A, Viver JM (2007). "Drug consumption and the risk of microscopic colitis". Am. J. Gastroenterol. 102 (2): 324–30. doi:10.1111/j.1572-0241.2006.00902.x. PMID 17100977.
- ^ Olivera AO (1997). "Sertraline and akathisia: spontaneous resolution". Biol. Psychiatry 41 (2): 241–2. PMID 9018398.
- ^ Review:Leo RJ (1996). "Movement disorders associated with the serotonin selective reuptake inhibitors". The Journal of clinical psychiatry 57 (10): 449–54. PMID 8909330.
- ^ Lauterbach EC, Meyer JM, Simpson GM (1997). "Clinical manifestations of dystonia and dyskinesia after SSRI administration". The Journal of clinical psychiatry 58 (9): 403–4. PMID 9378692.
- ^ Walker L (2002). "Sertraline-induced akathisia and dystonia misinterpreted as a panic attack". Psychiatric services (Washington, D.C.) 53 (11): 1477–8. PMID 12407283.
- ^ Hansen L (2001). "A critical review of akathisia, and its possible association with suicidal behaviour" 16 (7): 495–505. doi:10.1002/hup.325. PMID 12404546.
- ^ Hansen L, Kingdom D (2006). "Akathisia as a risk factor for suicide". The British journal of psychiatry : the journal of mental science 188: 192. doi:10.1192/bjp.188.2.192. PMID 16449715.
- ^ Fava M, Judge R, Hoog SL, Nilsson ME, Koke SC (2000). "Fluoxetine versus sertraline and paroxetine in major depressive disorder: changes in weight with long-term treatment". The Journal of clinical psychiatry 61 (11): 863—7. PMID 11105740.
- ^ a b Maina G, Albert U, Salvi V, Bogetto F (2004). "Weight gain during long-term treatment of obsessive-compulsive disorder: a prospective comparison between serotonin reuptake inhibitors". The Journal of clinical psychiatry 65 (10): 1365-71. PMID 15491240.
- ^ Schmitt JA, Kruizinga MJ, Riedel WJ (2001). "Non-serotonergic pharmacological profiles and associated cognitive effects of serotonin reuptake inhibitors". J. Psychopharmacol. (Oxford) 15 (3): 173–9. PMID 11565624.
- ^ Siepmann M, Grossmann J, Mück-Weymann M, Kirch W (2003). "Effects of sertraline on autonomic and cognitive functions in healthy volunteers". Psychopharmacology (Berl.) 168 (3): 293–8. doi:10.1007/s00213-003-1448-4. PMID 12692706.
- ^ Gorenstein C, de Carvalho SC, Artes R, Moreno RA, Marcourakis T (2006). "Cognitive performance in depressed patients after chronic use of antidepressants". Psychopharmacology (Berl.) 185 (1): 84–92. doi:10.1007/s00213-005-0274-2. PMID 16485140.
- ^ Hostetter A, Ritchie JC, Stowe ZN (2000). "Amniotic fluid and umbilical cord blood concentrations of antidepressants in three women". Biol. Psychiatry 48 (10): 1032-4. PMID 11082480.
- ^ Hendrick V, Stowe ZN, Altshuler LL, Hwang S, Lee E, Haynes D (2003). "Placental passage of antidepressant medications". The American journal of psychiatry 160 (5): 993-6. PMID 12727706.
- ^ Louik C, Lin AE, Werler MM, Hernández-Díaz S, Mitchell AA (2007). "First-trimester use of selective serotonin-reuptake inhibitors and the risk of birth defects". N. Engl. J. Med. 356 (26): 2675–83. doi:10.1056/NEJMoa067407. PMID 17596601.
- ^ Stowe ZN, Hostetter AL, Owens MJ, Ritchie JC, Sternberg K, Cohen LS, Nemeroff CB (2003). "The pharmacokinetics of sertraline excretion into human breast milk: determinants of infant serum concentrations". The Journal of clinical psychiatry 64 (1): 73–80. PMID 12590627.
- ^ Epperson N, Czarkowski KA, Ward-O'Brien D, Weiss E, Gueorguieva R, Jatlow P, Anderson GM (2001). "Maternal sertraline treatment and serotonin transport in breast-feeding mother-infant pairs". The American journal of psychiatry 158 (10): 1631-7. PMID 11578995.
- ^ a b Ferguson JM (2001). "The effects of antidepressants on sexual functioning in depressed patients: a review". The Journal of clinical psychiatry 62 Suppl 3: 22-34. PMID 11229450.
- ^ a b Croft H, Settle E, Houser T, Batey SR, Donahue RM, Ascher JA (1999). "A placebo-controlled comparison of the antidepressant efficacy and effects on sexual functioning of sustained-release bupropion and sertraline". Clinical therapeutics 21 (4): 643-58. doi:10.1016/S0149-2918(00)88317-4. PMID 10363731.
- ^ Levenson M, Holland C. Antidepressants and Suicidality in Adults: Statistical Evaluation. (Presentation at Psychopharmacologic Drugs Advisory Committee; December 13, 2006). Retrieved on 2007-05-13.
- ^ a b c Stone MB, Jones ML (November 17, 2006). CLINICAL REVIEW: RELATIONSHIP BETWEEN ANTIDEPRESSANT DRUGS AND SUICIDALITY IN ADULTS (PDF). Overview for December 13 Meeting of Psychopharmacologic Drugs Advisory Committee (PDAC) 11-74. FDA. Retrieved on 2007-09-22.
- ^ a b Levenson M, Holland C (November 17, 2006). Statistical Evaluation of Suicidality in Adults Treated with Antidepressants (PDF). Overview for December 13 Meeting of Psychopharmacologic Drugs Advisory Committee (PDAC) 75-140. FDA. Retrieved on 2007-09-22.
- ^ Pfizer Inc. (November 30, 2006). Memorandum from Pfizer Global Pharmaceuticals Re: DOCKET: 2006N-0414 –“SUICIDALITY DATA FROM ADULT ANTIDIPRESSANT TRIALS” ZOLOFT SERTRALINE HYDROCHLORIDE) TABLETS & ORAL CONCENTRATE BACKGROUND PACKAGE FOR DECEMBER 13 ADVISORY COMMITTEE (PDF). FDA DOCKET 2006N-0414. FDA. Retrieved on 2007-09-25.
- ^ CSM EXPERT WORKING GROUP ON THE SAFETY OF SELECTIVE SEROTONIN REUPTAKE INHIBITOR ANTIDEPRESSANTS (Decemver 2004). [www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con019472.pdf REPORT OF THE CSM EXPERT WORKING GROUP ON THE SAFETY OF SELECTIVE SEROTONIN REUPTAKE INHIBITOR ANTIDEPRESSANTS] (PDF). MHRA. Retrieved on 2007-09-25.
- ^ Gunnell D, Saperia J, Ashby D (2005). "Selective serotonin reuptake inhibitors (SSRIs) and suicide in adults: meta-analysis of drug company data from placebo controlled, randomised controlled trials submitted to the MHRA's safety review". BMJ 330 (7488): 385. doi:10.1136/bmj.330.7488.385. PMID 15718537. Retrieved on 2007-09-25.
- ^ a b Rosenbaum JF, Fava M, Hoog SL, Ascroft RC, Krebs WB (1998). "Selective serotonin reuptake inhibitor discontinuation syndrome: a randomized clinical trial". Biol. Psychiatry 44 (2): 77—87. PMID 9646889.
- ^ Meyer JH, Wilson AA, Sagrati S, Hussey D, Carella A, Potter WZ, Ginovart N, Spencer EP, Cheok A, Houle S (2004). "Serotonin transporter occupancy of five selective serotonin reuptake inhibitors at different doses: an [11C]DASB positron emission tomography study". The American journal of psychiatry 161 (5): 826–35. PMID 15121647.
- ^ a b Owens MJ, Knight DL, Nemeroff CB (2001). "Second-generation SSRIs: human monoamine transporter binding profile of escitalopram and R-fluoxetine". Biol. Psychiatry 50 (5): 345–50. PMID 11543737.
- ^ Narita N, Hashimoto K, Tomitaka S, Minabe Y (1996). "Interactions of selective serotonin reuptake inhibitors with subtypes of sigma receptors in rat brain". Eur. J. Pharmacol. 307 (1): 117–9. PMID 8831113.
- ^ a b Owens MJ, Morgan WN, Plott SJ, Nemeroff CB (1997). "Neurotransmitter receptor and transporter binding profile of antidepressants and their metabolites". J. Pharmacol. Exp. Ther. 283 (3): 1305–22. PMID 9400006.
- ^ a b c d e DeVane CL, Liston HL, Markowitz JS (2002). "Clinical pharmacokinetics of sertraline". Clinical pharmacokinetics 41 (15): 1247–66. PMID 12452737.
- ^ Kobayashi K, Ishizuka T, Shimada N, Yoshimura Y, Kamijima K, Chiba K (1999). "Sertraline N-demethylation is catalyzed by multiple isoforms of human cytochrome P-450 in vitro". Drug Metab. Dispos. 27 (7): 763–6. PMID 10383917.
- ^ a b c Obach RS, Cox LM, Tremaine LM (2005). "Sertraline is metabolized by multiple cytochrome P450 enzymes, monoamine oxidases, and glucuronyl transferases in human: an in vitro study". Drug Metab. Dispos. 33 (2): 262–70. doi:10.1124/dmd.104.002428. PMID 15547048.
- ^ Hamelin BA, Turgeon J, Vallée F, Bélanger PM, Paquet F, LeBel M (1996). "The disposition of fluoxetine but not sertraline is altered in poor metabolizers of debrisoquin". Clin. Pharmacol. Ther. 60 (5): 512–21. doi:10.1016/S0009-9236(96)90147-2. PMID 8941024.
- ^ Wang JH, Liu ZQ, Wang W, Chen XP, Shu Y, He N, Zhou HH (2001). "Pharmacokinetics of sertraline in relation to genetic polymorphism of CYP2C19". Clin. Pharmacol. Ther. 70 (1): 42–7. doi:10.1067/mcp.2001.116513. PMID 11452243.
- ^ a b Obach RS, Walsky RL, Venkatakrishnan K, Gaman EA, Houston JB, Tremaine LM (2006). "The utility of in vitro cytochrome P450 inhibition data in the prediction of drug-drug interactions". J. Pharmacol. Exp. Ther. 316 (1): 336–48. doi:10.1124/jpet.105.093229. PMID 16192315.
- ^ Ozdemir V, Naranjo CA, Herrmann N, Shulman RW, Sellers EM, Reed K, Kalow W (1998). "The extent and determinants of changes in CYP2D6 and CYP1A2 activities with therapeutic doses of sertraline". Journal of clinical psychopharmacology 18 (1): 55–61. PMID 9472843.
- ^ Alfaro CL, Lam YW, Simpson J, Ereshefsky L (1999). "CYP2D6 status of extensive metabolizers after multiple-dose fluoxetine, fluvoxamine, paroxetine, or sertraline". Journal of clinical psychopharmacology 19 (2): 155–63. PMID 10211917.
- ^ Alfaro CL, Lam YW, Simpson J, Ereshefsky L (2000). "CYP2D6 inhibition by fluoxetine, paroxetine, sertraline, and venlafaxine in a crossover study: intraindividual variability and plasma concentration correlations". Journal of clinical pharmacology 40 (1): 58–66. PMID 10631623.
- ^ Preskorn SH, Greenblatt DJ, Flockhart D, Luo Y, Perloff ES, Harmatz JS, Baker B, Klick-Davis A, Desta Z, Burt T (2007). "Comparison of duloxetine, escitalopram, and sertraline effects on cytochrome P450 2D6 function in healthy volunteers". Journal of clinical psychopharmacology 27 (1): 28–34. PMID 17224709.
- ^ Hamilton SP, Nunes EV, Janal M, Weber L (2000). "The effect of sertraline on methadone plasma levels in methadone-maintenance patients". The American journal on addictions / American Academy of Psychiatrists in Alcoholism and Addictions 9 (1): 63–9. PMID 10914294.
- ^ DeVane CL, Donovan JL, Liston HL, Markowitz JS, Cheng KT, Risch SC, Willard L (2004). "Comparative CYP3A4 inhibitory effects of venlafaxine, fluoxetine, sertraline, and nefazodone in healthy volunteers". Journal of clinical psychopharmacology 24 (1): 4–10. doi:10.1097/01.jcp.0000104908.75206.26. PMID 14709940.
- ^ Lacasse J, Leo J (2005). "Serotonin and depression: a disconnect between the advertisements and the scientific literature". PLoS Med 2 (12): e392. doi:10.1371/journal.pmed.0020392.g001. PMID 16268734. Free full text, open-access source
- ^ Food and Drug Administration Division of Drug Marketing Advertising and Communications. (2005) Zoloft warning letter.. Retrieved on 2007-11-03.
- ^ Regina v Hawkins [2001 NSWSC 420]. New South Wales Supreme Court (May 24, 2001). Retrieved on 2007-11-03.
- ^ Business Wire (July 23, 2004). "Suit Claims Pfizer Conceals Evidence and Misleads Doctors and Patients About Safety and Effectiveness of Zoloft". Press release. Retrieved on 2007-04-19.
- ^ Enter the case number "BC 318871" into the form to see the summary of the case stating that the suit was dismissed. The images of the case documents are available for a nominal price. Los Angeles Superior Court - Civil Case Summary (2005-05-31). Retrieved on 2007-11-04. “It is thereby ordered, adjudged and decreed that this action is dismissed and that Defendant Pfizer Inc is awarded its costs of suit incurred therein.”
Psychoanaleptics: antidepressants (N06A) |
---|
MAOIs | Iproclozide • Iproniazid • Isocarboxazid • Nialamide • Pargyline • Phenelzine • Rasagiline • Selegiline • Toloxatone • Tranylcypromine RIMAs: Brofaromine • Beta-carbolines (Harmaline) • Moclobemide |
---|
RIs |
S RI |
SS RI (Alaproclate, Citalopram, Dapoxetine, Escitalopram, Etoperidone, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Zimelidine) • TCAs/Tetras (Clomipramine, Nefazodone, Trazodone) |
N RI / A RI |
Atomoxetine • Maprotiline • Reboxetine • Viloxazine • TCAs/Tetras (Amitriptyline, Amoxapine, Butriptyline, Desipramine/Lofepramine, Dibenzepin, Dothiepin, Doxepin, Imipramine, Iprindole, Melitracen, Nortriptyline, Opipramol, Protriptyline, Trimipramine, Maprotiline) |
D RI |
Vanoxerine • Phenmetrazine • TCAs (Amineptine) |
SN RI |
Bicifadine • Desvenlafaxine • Duloxetine • Milnacipran • Nefazodone • Venlafaxine |
ND RI |
Bupropion |
SND RI |
Brasofensine • Tesofensine • Nomifensine |
|
---|
SSREs | Tianeptine |
---|
AAs | Tetras (Mianserin, Mirtazapine) |
---|
|