Extended-release Trazodone in Major Depressive Disorder: A Randomized, Double-blind, Placebo-controlled Study.

ABSTRACT:

Objective

To investigate the efficacy, safety, and clinical benefit of a once-daily formulation of trazodone (Trazodone Contramid((c)) OAD) in the treatment of major depressive disorder.

Design/participants

In this double-blind study, 412 patients with major depressive disorder (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria) were randomized 1:1 to receive either Trazodone Contramid OAD (150 to 375mg) or placebo. Treatment was titrated over two weeks to each individual optimal dose. Patients then continued six weeks of treatment; further dose adjustments were allowed based on efficacy and tolerability.

Measurements

The primary end point was change in the 17-item Hamilton Depression Rating Scale total score from baseline to last study vi

SUBMITTER: Sheehan DV 

PROVIDER: S-EPMC2719441 | biostudies-literature | 2009 May

REPOSITORIES: biostudies-literature