Gepirone Extended-Release: New Evidence for Efficacy in the Treatment of Major Depressive Disorder
J Clin Psychiatry 2003;64(3):243-249
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Objective: To assess the efficacy and
tolerability of the 5-HT1A agonist gepirone in
extended-release formulation (gepirone-ER) versus placebo in
patients with major depressive disorder.
Method: Patients aged 18 to 70 years were
eligible if they satisfied DSM-IV criteria for moderate-to-severe
major depressive disorder and had a baseline 17-item Hamilton
Rating Scale for Depression (HAM-D-17) score >= 20. After a 4-
to 7-day placebo washout period, patients were randomly assigned
to receive either placebo (N = 106) or gepirone-ER (20-80 mg/day)
(N = 103) for 56 days. Assessments were done at weeks 1-4, 6, and
Results: Mean change from baseline in
HAM-D-17 score within the intent-to-treat group (gepirone, N =
101; placebo, N = 103) was significantly greater with gepirone-ER
than placebo at weeks 3 (p = .013) and 8 (p = .018).
Significantly (p < .05) more patients receiving gepirone-ER
than placebo were HAM-D-17 responders at weeks 3 (33.7% vs.
18.8%, respectively) and 4 (38.6% vs. 24.8%, respectively) and
HAM-D-17 remitters at weeks 6 (24.8% vs. 13.9%, respectively) and
8 (28.7% vs. 14.9%, respectively). Mean change from baseline for
HAM-D-25 total score was significantly (p <= .05) greater with
gepirone-ER at all assessments except week 6. The proportion of
HAM-D-25 responders was significantly greater (p <= .05) with
gepirone-ER at weeks 3 and 8. Gepirone-ER was well tolerated:
9.8% of the gepirone-ER group and 2.8% of the placebo group
discontinued due to adverse events. Common adverse events were
considered mild and included dizziness, nausea, and insomnia.
Gepirone-ER did not differ statistically compared with placebo in
weight gain or sedation. Furthermore, preliminary evidence
suggested that gepirone-ER may not be associated with sexual
dysfunction. No serious adverse events occurred in
Conclusion: Gepirone-ER is effective for
the short-term treatment of major depressive disorder and is well