Efficacy, safety, and tolerability of fixed-dose desvenlafaxine 50 and 100 mg/day for major depressive disorder in a placebo-controlled trial

Aug 16, 2008International clinical psychopharmacology

Effectiveness and safety of fixed doses of desvenlafaxine (50 and 100 mg/day) for major depression in a placebo-controlled trial

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Abstract

In a trial with 483 patients, desvenlafaxine 100 mg/day showed a significant mean change of -13.7 on the Hamilton Rating Scale for Depression compared to placebo.

Desvenlafaxine 50 mg/day resulted in a significant mean change of -13.2 on the Hamilton Rating Scale for Depression.
Both dosages of desvenlafaxine (50 mg and 100 mg) demonstrated significant improvements in Clinical Global Impressions-Improvement scores compared to placebo.
Common adverse events associated with desvenlafaxine included nausea, dizziness, insomnia, constipation, fatigue, anxiety, and decreased appetite.
Desvenlafaxine was generally well tolerated among participants in the study.

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The objective of this study was to assess the efficacy, safety, and tolerability of desvenlafaxine (administered as desvenlafaxine succinate) 50 and 100 mg/day for major depressive disorder (MDD). A multicenter, randomized, double-blind, placebo-controlled trial was conducted in Europe and South Africa. Outpatients with MDD received fixed-dose desvenlafaxine (50 or 100 mg/day) or placebo for 8 weeks. The primary efficacy variable was the 17-item Hamilton Rating Scale for Depression total score; secondary measures included Clinical Global Impressions-Improvement scores. The intent-to-treat population included 483 patients: desvenlafaxine 50 mg (n=164), desvenlafaxine 100 mg (n=158), and placebo (n=161). At the last-observation-carried-forward analysis (final evaluation) using analysis of covariance, adjusted mean changes from baseline on the Hamilton Rating Scale for Depression were significantly greater for both desvenlafaxine 50 mg (-13.2; P=0.002) and 100 mg (-13.7; P<0.001) versus placebo (-10.7). Significant differences on the Clinical Global Impressions-Improvement scores were observed for desvenlafaxine 50 mg (P=0.002) and 100 mg (P<0.001) versus placebo. Both doses of desvenlafaxine were generally well tolerated. The most common treatment-emergent adverse events were nausea, dizziness, insomnia, constipation, fatigue, anxiety, and decreased appetite. Fixed doses of desvenlafaxine 50 and 100 mg/day are safe, generally well tolerated, and effective at a clinically relevant level for the treatment of MDD.

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Efficacy, safety, and tolerability of fixed-dose desvenlafaxine 50 and 100 mg/day for major depressive disorder in a placebo-controlled trial

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