Treatment-related adverse events and outcome in a clinical trial of fluoxetine for major depressive disorder

Abstract

Treatment-related adverse events (TRAEs), particularly those that occur early on, may increase the likelihood for premature discontinuation of antidepressants. The purpose of this study was to examine the relationship between TRAEs and outcome in depressed outpatients enrolled in an 8-week, 20 mg, open trial of fluoxetine. A total of 384 patients (54.7% women, mean age 39.9 +/- 10.5 years) were enrolled in the trial. Study visits occurred at baseline and every other week. Somatic complaints were assessed during each study visit. Somatic complaints that, in the opinion of the evaluating physician, were probably related or related to treatment with fluoxetine were entered in the analysis as TRAEs. We then tested whether 1) developing at least one TRAE, 2) developing at least one moderate or severe TRAE, 3) the number of TRAEs reported during the entire trial, or 4) the number of TRAEs reported during each 2-week interval predicted whether patients would respond to fluoxetine, or prematurely discontinue treatment. None of the above scores predicted whether patients responded to or prematurely discontinued the trial. These findings failed to reveal any relationship between side effects and treatment outcome for patients with MDD enrolled in an 8-week, 20 mg, fixed dose, open trial of fluoxetine.