Double-blind, placebo-substitution study of nefazodone in the prevention of relapse during continuation treatment of outpatients with major depression

Feiger, Alan D.; Bielski, Robert J.; Bremner, J. Douglas; Heiser, Jon F.; Trivedi, Madhukar H.; Wilcox, Charles S.; Roberts, Douglas L.; Kensler, Terry T.; McQuade, Robert D.; Kaplita, Stephen; Archibald, Donald

doi:10.1097/00004850-199901000-00002

Cited by 57 publications

(23 citation statements)

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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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“…Twelve trials (13 placebo comparisons) were shorter than 1 year for the randomized followup (18)(19)(20)(21)(22)(23)(24)(25)(26)(27)29,40). These trials provide consistent evidence in favor of active drug over placebo, with the majority representing the efficacy of relapse prevention.…”

Section: Placebo-controlled Trialsmentioning

confidence: 99%

“…Trials shorter than 1 year-Twelve trials were included in our relative risk meta-analysis of trials lasting less than 1 year after randomization ( Figure 1): one on bupropion (18), three on citalopram (19,27,40), one on escitalopram (20), three on fluoxetine (21,22,29), and one each on mirtazapine (23), nefazodone (24), sertraline (25), and venlafaxine (26). The pooled relative risk of relapse was 0.54 (95% CI 0.46 to 0.62) and the NNT to prevent one additional relapse over a mean time of 8 months was 5 (95% CI: 4-6).…”

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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“…Similar to trazodone, it has potent selective 5HT2 antagonistic properties and weakly inhibits the reuptake of serotonin and norepinephrine (Feiger et al, 1999). A study that assessed nefazodone, psychotherapy, as well as a combination of psychotherapy and nefazodone in chronically depressed patients revealed response rates of 55% in the nefazodone group, 52% in the psychotherapy group, and 85% in the combined-treatment group (Keller et al, 2000).…”

Section: Nefazodonementioning

confidence: 99%

Emerging antidepressants to treat major depressive disorder

Block

Nemeroff

2014

Asian Journal of Psychiatry

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Double-blind, placebo-substitution study of nefazodone in the prevention of relapse during continuation treatment of outpatients with major depression

Cited by 57 publications

References 0 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

Emerging antidepressants to treat major depressive disorder

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