A double-blind, randomized, placebo-controlled study assessing the efficacy and tolerability of desvenlafaxine 10 and 50 mg/day in adult outpatients with major depressive disorder

Mar 23, 2013BMC psychiatry

Desvenlafaxine 10 and 50 mg daily for major depression: a double-blind placebo-controlled study of effectiveness and side effects in adults

AI simplified

Circadian Biology on OpenScience ↗PubMed ↗DOI ↗

Abstract

The study involved 673 patients receiving either desvenlafaxine (10 or 50 mg/day) or placebo.

No significant difference was observed in the change from baseline in depression scores between desvenlafaxine 10 mg/day (-9.28) and 50 mg/day (-8.92) compared to placebo (-8.42).
Rates of treatment response and remission did not differ among the treatment groups.
Discontinuation due to adverse events occurred in 1.8% of placebo patients and 0.9% and 1.8% of those receiving desvenlafaxine 10 mg/day and 50 mg/day, respectively.
The overall rates of treatment-emergent adverse events were similar between both doses of desvenlafaxine and placebo.
Findings suggest that 50 mg may be the minimum effective dose of desvenlafaxine for treating major depressive disorder, according to a companion study.

AI simplified

BACKGROUND: In an effort to establish the lowest effective dose of desvenlafaxine (administered as desvenlafaxine succinate), we assessed the efficacy, safety, and tolerability of 10- and 50-mg/day desvenlafaxine vs placebo for the treatment of major depressive disorder.

METHODS: Adult outpatients with DSM-IV-defined major depressive disorder and a 17-item Hamilton Rating Scale for Depression (HAM-D(17)) total score ≥20 were randomly assigned to receive placebo or desvenlafaxine (10 or 50 mg/day) after a 6- to 14-day single-blind placebo lead-in period in an 8-week, phase 3, fixed-dose trial. The primary efficacy measure was change from baseline in the HAM-D(17) score analyzed using analysis of covariance. Efficacy analyses were conducted with the intent-to-treat population, using the last observation carried forward.

RESULTS: The intent-to-treat population included 673 patients. Change from baseline to final evaluation in adjusted HAM-D(17) total scores was not significantly different comparing desvenlafaxine 10 mg/day (-9.28) and desvenlafaxine 50 mg/day (-8.92) with placebo (-8.42). There were no differences among treatment groups in the rates of treatment response or remission. Discontinuations due to adverse events occurred in 1.8%, 0.9%, and 1.8% of patients in the placebo and desvenlafaxine 10- and 50-mg/day groups, respectively. Overall rates of treatment-emergent adverse events with both doses were similar to placebo.

CONCLUSIONS: Both doses of desvenlafaxine failed to separate from placebo. However, in a companion study reported separately, desvenlafaxine 50 mg, but not 25 mg, separated from placebo. Taken together, these studies suggest that 50 mg is the minimum effective dose of desvenlafaxine for the treatment of major depressive disorder. CLINICALTRIALS.GOV IDENTIFIER: NCT00863798 http://clinicaltrials.gov/ct2/show/NCT00863798?term=00863798&rank=1.

Full Text

We can’t show the full text here under this license. Use the link below to read it at the source.

View full text (PDF) ↗View full text (HTML) ↗View full text ↗

A double-blind, randomized, placebo-controlled study assessing the efficacy and tolerability of desvenlafaxine 10 and 50 mg/day in adult outpatients with major depressive disorder

Abstract

Full Text

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the circadian biology brief

Abstract

Full Text

Related papers

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the circadian biology brief