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Investigational Gepirone Extended Release Shows Efficacy for Major Depressive Disorder: Presented at ECNP

By Bruce Sylvester
Special to DG News

BARCELONA, SPAIN -- October 9, 2002 -- Gepirone-ER (extended release), an investigational 5-HT1A agonist, shows efficacy in the treatment of major depressive disorder and is well-tolerated at doses of 40 to 80 mg/day, researchers reported here today at the 15^th Congress of the European College of Neuropsychopharmacology.

The research team saw early and significant effects of gepirone-ER on depression, said Alan Feiger, MD, Clinical Director of Feiger Health Research in Wheat Ridge, Colorado, with significantly more subjects than placebo becoming responders at weeks 3 and 4, and significantly more subjects than placebo achieving remission at weeks 6 and 8.

The double blind, randomised, eight-week trial enrolled 204 subjects aged 18 to 70 years who had a diagnosis of moderate-to-severe major depressive disorder (MDD), according to the Diagnostic and Statistical Manual - Revision IV, and a baseline Hamilton Rating Scale for Depression (HAM-D)-17 score of 20 or greater.

Following an initial four to seven day placebo washout period, the researchers randomised subjects to either placebo or gepirone-ER 20 mg/day. They were titrated to 40 mg/day on day 4, 60 mg/day on day 7, and 80 mg/day on day 14. They received 40-80 mg/day for the rest of the study.

Efficacy was evaluated by the change in the HAMD-17 total score from baseline to end point.

Mean HAMD-17 change was significantly greater with gepirone than placebo at weeks 3 (p=0.013) and 8 (p=0.018). Mean baseline-to-end point HAMD-17 change was 9.77 points at week 8 for gepirone compared with a mean change of 7.43 points for placebo.

Significantly more gepirone than placebo subjects were HAMD-17 responders at weeks 3 and 4, and HAMD-17 remitters at weeks 6 and 8 (p=0.05).

Except for week 6, the mean change from baseline for the HAMD-25 total score was significantly greater for gepirone than placebo (p=0.05). The proportion of HAMD-25 responders was also significantly higher for gepirone than placebo at weeks 3 and 8 (p=0.05).

The researchers reported that 9.8 percent of patients in the gepirone group and 2.8 percent in the placebo group discontinued treatment due to adverse events.

According to the researchers, active treatment was not associated with weight gain, sedation, or sexual dysfunction, and no serious adverse events were noted.

The research was supported by Organon Inc.

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