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J Clin Psychiatry. 2014 Mar;75(3):205-14. doi: 10.4088/JCP.13r08722.

Review of maintenance trials for major depressive disorder: a 25-year perspective from the US Food and Drug Administration.

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1
Division of Psychiatry Products, HFD-130, Food and Drug Administration, 10903 New Hampshire Ave, Bldg 22, Rm 4159, Silver Spring, MD 20993-0002 silvana.borges@fda.hhs.gov.

Abstract

OBJECTIVE:

The maintenance efficacy of antidepressants is usually assessed in postmarketing studies with a randomized withdrawal design. This report explores differences in relapse rates, trial characteristics, and success rates in maintenance efficacy studies submitted to the US Food and Drug Administration (FDA) over a 25-year period.

DATA SOURCES:

Clinical data from all maintenance trials with antidepressants submitted to FDA between 1987 and 2012.

STUDY SELECTION:

Efficacy data were compiled from 15 maintenance clinical trials in adults diagnosed with major depressive disorder according to DSM-III or DSM-IV criteria.

DATA EXTRACTION:

Trial characteristics, relapse rates, and time to relapse in each study were examined.

RESULTS:

Relapse rates were significantly lower (P < .05) in the drug arm than in the placebo arm in every study, with a mean relapse rate difference of 18% and an average percent reduction in relapse rate of 52% compared to placebo. Only 6% of the relapse events occurred in the first 2 weeks of the double-blind phase. The separation between treatment arms continued to increase throughout the double-blind phase only in the trial with longest response stabilization period.

CONCLUSIONS:

Antidepressant maintenance trials have a high rate of success, indicating a benefit of continuing drug treatment after initial response to an antidepressant. This benefit appears to result mainly from a decreased rate of recurrent depression rather than from an effect of drug withdrawal in the placebo groups.

PMID:
24717376
DOI:
10.4088/JCP.13r08722
[Indexed for MEDLINE]
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