Gepirone Extended-Release: New Evidence for Efficacy in the Treatment of Major Depressive Disorder
Alan D. Feiger, Jon F. Heiser, Ram K. Shrivastava, Kenneth J. Weiss, Ward T. Smith, J. M. A. Sitsen, and Michael Gibertini
J Clin Psychiatry 2003;64(3):243-249
© Copyright 2015 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
8.
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
gepirone-treated patients.
Conclusion: Gepirone-ER is effective for
the short-term treatment of major depressive disorder and is well
tolerated.