A Randomized, Placebo-Controlled Trial of Sertraline for Prophylactic Treatment of Highly Recurrent Major Depressive Disorder

Lépine, Jean‐Pierre; Caillard, Vincent; Bisserbe, J.C.; Troy, S.; Hotton, Jean-Michel; Boyer, Patrice

doi:10.1176/appi.ajp.161.5.836

Cited by 75 publications

(35 citation statements)

References 18 publications

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“…In total, the authors had reported in 65 papers on various studies of antidepressant maintenance trials, but 36 of these had not documented suicides or suicide attempts or had not provided data upon request. The following 29 studies were included in our quantitative analysis: Blumenthal et al [30], Cheung et al [31], Doogan and Caillard [32], Emslie et al [33], Feiger et al [34], Goodwin et al [35], Kamijima et al [36], Kishimoto et al [37], Klysner et al [38], Kornstein et al [39], Lepine et al [40], Licht et al [41], Lustman et al [42], McGrath et al [43], Montgomery et al [44], Montgomery and Dunbar [45], Old Age Depression Interest Group [46], Perahia et al [47], Reynolds et al [48], Robinson et al [49], Rosenthal et al [50], Rouillon et al [51], Schmidt et al [52], Shiovitz et al [53], Stewart et al [54], Terra and Montgomery [55], Thase et al [56], Versiani et al [57], Weihs et al [58]. …”

Section: Resultsmentioning

confidence: 99%

Suicides and Suicide Attempts during Long-Term Treatment with Antidepressants: A Meta-Analysis of 29 Placebo-Controlled Studies Including 6,934 Patients with Major Depressive Disorder

Braun¹,

Bschor

Franklin

et al. 2016

Psychother Psychosom

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Background: It is unclear whether antidepressants can prevent suicides or suicide attempts, particularly during long-term use. Methods: We carried out a comprehensive review of long-term studies of antidepressants (relapse prevention). Sources were obtained from 5 review articles and by searches of MEDLINE, PubMed Central and a hand search of bibliographies. We meta-analyzed placebo-controlled antidepressant RCTs of at least 3 months' duration and calculated suicide and suicide attempt incidence rates, incidence rate ratios and Peto odds ratios (ORs). Results: Out of 807 studies screened 29 were included, covering 6,934 patients (5,529 patient-years). In total, 1.45 suicides and 2.76 suicide attempts per 1,000 patient-years were reported. Seven out of 8 suicides and 13 out of 14 suicide attempts occurred in antidepressant arms, resulting in incidence rate ratios of 5.03 (0.78-114.1; p = 0.102) for suicides and of 9.02 (1.58-193.6; p = 0.007) for suicide attempts. Peto ORs were 2.6 (0.6-11.2; nonsignificant) and 3.4 (1.1-11.0; p = 0.04), respectively. Dropouts due to unknown reasons were similar in the antidepressant and placebo arms (9.6 vs. 9.9%). The majority of suicides and suicide attempts originated from 1 study, accounting for a fifth of all patient-years in this meta-analysis. Leaving out this study resulted in a nonsignificant incidence rate ratio for suicide attempts of 3.83 (0.53-91.01). Conclusions: Therapists should be aware of the lack of proof from RCTs that antidepressants prevent suicides and suicide attempts. We cannot conclude with certainty whether antidepressants increase the risk for suicide or suicide attempts. Researchers must report all suicides and suicide attempts in RCTs.

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Section: Resultsmentioning

confidence: 99%

Suicides and Suicide Attempts during Long-Term Treatment with Antidepressants: A Meta-Analysis of 29 Placebo-Controlled Studies Including 6,934 Patients with Major Depressive Disorder

Braun¹,

Bschor

Franklin

et al. 2016

Psychother Psychosom

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“…The unadjusted frequency of relapse was 22% for active treatment, compared with 42% for placebo. An additional 11 RCTs were 1 year or longer (28,(30)(31)(32)(33)(34)(35)(36)(37)(38)(39). These trials also provide consistent evidence in favor of active treatment over placebo, with the majority representing recurrence prevention during maintenance-phase treatment.…”

Section: Placebo-controlled Trialsmentioning

confidence: 88%

“…Trials 1 year or longer-Eleven trials provided data points for followup of 1 year or more ( Figure 2): one on citalopram (28), one on escitalopram (38), one on fluvoxamine (30), one on nefazodone (31), two on paroxetine (32,37), four on sertraline (33)(34)(35)39), and one on venlafaxine (36). Trials consistently favored active treatment over placebo for preventing relapse and/or recurrence, although differences were not always statistically significant.…”

Section: Meta-analysismentioning

confidence: 99%

Meta-analysis of Major Depressive Disorder Relapse and Recurrence With Second-Generation Antidepressants

Hansen¹,

Gaynes²,

Thieda³

et al. 2008

Psychiatric Services

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Objective-To review data on the efficacy and effectiveness of second-generation antidepressants for preventing major depression relapse and recurrence during continuation and maintenance phase treatment, respectively.Methods-MEDLINE®, EMBASE, and PsychLit; the Cochrane Library; and the International Pharmaceutical Abstracts were searched from January 1980 through April 2007 for reviews, randomized controlled trials, meta-analyses, and observational studies. Two persons independently reviewed abstracts and full text articles using a structured data abstraction form to ensure consistency in appraisal and data extraction.Findings-Four comparative trials and 23 placebo controlled trials that addressed relapse or recurrence prevention were included. Results of comparative trials have not demonstrated statistically significant differences between duloxetine and paroxetine, fluoxetine and sertraline, fluvoxamine and sertraline, and trazodone and venlafaxine. Pooled data for the class of secondgeneration antidepressants compared with placebo suggest a relatively large effect size that persists over time. The number needed to treat to prevent one additional relapse or recurrence is 5 (95% CI 4 to 6). Differences in the length of open-label treatment prior to randomization, drug type, and trial duration did not affect pooled estimates of relapse rates (P = 0.716, P = 0.507, and P = 0.480, aCorresponding author and reprint address:

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“…Otherwise, the rates were extracted from the survival graph figures in the original reports. All of the studies satisfied the 24 week time point, 9 out of 11 studies satisfied the 48 week time point (Gilaberte et al, 2001;Hochstrasser et al, 2001;Keller et al, 1998;Klysner et al, 2002;Kocsis et al, 2007;Kornstein et al, 2006;Lepine et al, 2004;McGrath et al, 2006;Perahia et al, 2006;Reynolds et al, 1999;Sackeim et al, 2001), 4 out of 11 studies satisfied the 72 week time point (Hochstrasser et al, 2001;Keller et al, 1998;Lepine et al, 2004;Reynolds et al, 1999) and only 1 study satisfied the 96 week time point (Reynolds et al, 1999) (Figure 1). …”

Section: Information Retrievalmentioning

confidence: 98%

“…A different approach is to only randomize those patients who had not experienced a relapse after 2 months of masked placebo treatment. By doing so, the study selects for only the patients in remission and not those whose prophylactic therapy is masking an underlying, unremitting depression (Lepine et al, 2004).…”

Section: Introductionmentioning

confidence: 99%

Relapse rates with long‐term antidepressant drug therapy: a meta‐analysis

Williams

Simpson

et al. 2009

Human Psychopharmacology

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A Randomized, Placebo-Controlled Trial of Sertraline for Prophylactic Treatment of Highly Recurrent Major Depressive Disorder

Abstract: Among remitted patients with a history of multiple depressive episodes, sertraline at a dose of either 50 or 100 mg/day prevented recurrences significantly more than did placebo.

Cited by 75 publications

References 18 publications

Suicides and Suicide Attempts during Long-Term Treatment with Antidepressants: A Meta-Analysis of 29 Placebo-Controlled Studies Including 6,934 Patients with Major Depressive Disorder

Suicides and Suicide Attempts during Long-Term Treatment with Antidepressants: A Meta-Analysis of 29 Placebo-Controlled Studies Including 6,934 Patients with Major Depressive Disorder

Meta-analysis of Major Depressive Disorder Relapse and Recurrence With Second-Generation Antidepressants

Relapse rates with long‐term antidepressant drug therapy: a meta‐analysis

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