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Original Research

Gepirone Extended-Release Treatment of Anxious Depression: Evidence From a Retrospective Subgroup Analysis in Patients With Major Depressive Disorder

Jonathan E. Alpert, MD, PhD; Dana A. Franznick, PharmD; Steven B. Hollander,  MD; and Maurizio Fava, MD

Published: August 16, 2004

Article Abstract

Objective: To evaluate the efficacy and tolerability of gepirone extended-release (ER) tablets in patients with major depressive disorder (MDD) and high ratings of anxiety (anxious depression).

Method: This subgroup analysis was derived from an 8-week, double-blind, placebo-controlled study of gepirone ER in patients with MDD. Male and female patients 18 to 69 years of age who met DSM-IV criteria for MDD and had high ratings of anxiety (Hamilton Rating Scale for Depression [HAM-D-17] total score >= 20 and HAM-D-17 factor I [anxiety/somatization] score > 6) were included in this subgroup analysis. Eligible patients with anxious depression were randomly assigned to receive either placebo or gepirone ER, 20 mg to 80 mg daily. Patient assessments were performed at weeks 1, 2, 3, 4, 6, and 8. Treatment efficacy was evaluated by mean HAM-D-17 total scores and mean changes from baseline in (1) HAM-D-17 total scores, (2) HAM-D-17 factor I (anxiety/somatization) scores, and (3) HAM-D-17 item 12 (anxiety, psychic) scores. All statistical tests were 2-sided and considered statistically significant if the p value was = 50% decrease from baseline) or remission criterion (HAM-D-17 total score <= 7).

Results: Gepirone ER-treated patients (N = 58) experienced a statistically significant (p < .05) reduction in mean HAM-D-17 total score at week 3, 6, and 8 compared with placebo-treated patients (N = 75). A statistically significant effect (p < .05) in favor of gepirone ER was observed in mean change from baseline in HAM-D-17 total scores and for HAM-D factor I (anxiety/somatization) scores from week 2 onward. A statistically significant (p <= .01) effect in favor of gepirone ER was observed in HAM-D-17 item 12 (anxiety, psychic) scores throughout the 8-week trial. There were significantly more patients in the gepirone ER group compared with the placebo group who were HAM-D-17 responders (p < .05) at endpoint and who met the criteria for HAM-D-17 remission at week 3 (p < .05) and weeks 6 and 8 (p < .01). Overall, gepirone ER was well tolerated, with rates of weight gain and sexual dysfunction comparable to placebo. Adverse events were generally mild to moderate. The most commonly reported adverse events were dizziness and nausea.

Conclusions: Gepirone ER is an effective and well-tolerated treatment for patients with anxious depression.

Volume: 65

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