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Title: CINP: Extended Release Gepirone May Improve Sexual Function in Depressive Patients
URL: http://www.pslgroup.com/dg/217266.htm
Doctor's Guide
June 28, 2002


By Danny Kucharsky

Special to DG News

MONTREAL, QC -- June 28, 2002 -- Gepirone extended-release may have a positive effect on sexual function in patients with major depressive disorder, according to a placebo-controlled trial.

The researchers presented the findings here on June 27th at the 23rd Congress of the Collegium Internationale Neuro-Psychopharmacologicum (CINP).

A subgroup analysis of an eight-week, randomised, double-blind, parallel group, multisite study found that gepirone extended-release (ER), a 5HT1A agonist and antidepressant, had a beneficial effect in a combined group of men and women with major depressive disorder (MDD) as well as in a women-only group with MDD.

However, the same beneficial effect was not seen in the men-only MDD group. The low number of patients in this data set may have contributed to the lack of a statistically significant effect, investigators said.

According to lead investigator Dr. Jonathan Davidson, of Duke University Medical Center in Durham, North Carolina, United States, sexual dysfunction in patients with MDD has the potential to not only decrease quality of life, but also to inhibit medication compliance, relapse prevention, and recovery.

In patients with MDD, about 40 percent of men and 50 percent of women report decreased libido and arousal difficulties, and about 15 to 20 percent of individuals have orgasm difficulties, the investigators said. In addition, other classes of antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), have been reported to induce sexual dysfunction in 34 to 70 percent of patients.

In the study, sexual function was assessed at baseline and end point with the Derogatis Interview of Sexual Function -- Self-Report (DISF-SR), which assesses cognition/fantasy, arousal, behaviour, orgasm, and drive. Increases in DISF-SR scores indicate improved sexual function.

Baseline demographics were comparable in the subgroup analysis between gepirone-ER and placebo. Gepirone-ER was initiated at a dose of 20 mg once daily and increased to 40 mg once daily at day 4. Gepirone-ER could be increased to 80 mg once daily after day 14, depending on tolerability and therapeutic response. From then on, the dose was adjusted within the range of 40 to 80 mg once daily.

The 65 patients receiving gepirone-ER showed a statistically significant difference in sexual function compared to the 76 patients receiving placebo on total score mean change from baseline to end point (p=0.011). DISF-SR total score increased by 10.3 for the gepirone-ER group and declined by 0.4 for the placebo group.

DISF-SR total score increased by 10.0 among the 46 women treated with gepirone-ER; DISF-SR total score declined by 1.5 among the 42 women in the placebo group (p=0.043).

Among 19 men treated with gepirone-ER, there was a DISF-SR total score increase of 11.1, compared to a 1.1 increase among the 31 men in the placebo group. However, this effect was not statistically significant.

Dr. Davidson noted that additional studies analysing the effect of gepirone-ER compared to SSRIs on sexual function are ongoing.

The research was supported by funding from Organon Inc.

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