Gepirone extended-release: new evidence for efficacy in the treatment of major depressive disorder.

Abstract

OBJECTIVE:

To assess the efficacy and tolerability of the 5-HT(1A) 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 > or = 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 < pr =.05) greater with gepirone-ER at all assessments except week 6. The proportion of HAM-D-25 responders was significantly greater (p < or =.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.

• Authors: Alan D Feiger, Jon F Heiser, Ram K Shrivastava, Kenneth J Weiss, Ward T Smith, J M A Sitsen, Michael Gibertini
• Journal: The Journal of clinical psychiatry (J Clin Psychiatry) Vol. 64 Issue 3 Pg. 243-9 (Mar 2003) ISSN: 0160-6689 [Print] United States
• PMID: 12716264 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Delayed-Action Preparations
• Placebos
• Pyrimidines
• Serotonin Receptor Agonists
• gepirone

Topics

• Adolescent
• Adult
• Aged
• Ambulatory Care
• Delayed-Action Preparations
• Depressive Disorder (diagnosis, drug therapy)
• Dizziness (chemically induced)
• Double-Blind Method
• Humans
• Middle Aged
• Nausea (chemically induced)
• Placebos
• Psychiatric Status Rating Scales
• Pyrimidines (administration & dosage, adverse effects, therapeutic use)
• Serotonin Receptor Agonists (administration & dosage, adverse effects, therapeutic use)
• Severity of Illness Index
• Sleep Initiation and Maintenance Disorders (chemically induced)
• Treatment Outcome