Treating Sexual Dysfunction From Selective Serotonin Reuptake Inhibitor (SSRI) Medication: a Study Comparing Requip CR to Placebo
Antidepressant medicines sometimes cause sexual side effects. The purpose of this study is to determine whether the sexual dysfunction sometimes caused by selective serotonin reuptake inhibitor (SSRI) antidepressant medications can be reversed by treatment with Requip (ropinirole), a medicine which is used to treat Parkinson's Disease and restless leg syndrome.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Treatment of Sexual Dysfunction Secondary to Antidepressant Pharmacotherapy: A Double-Blind Comparison of Requip (Ropinirole) vs. Placebo in Patients Taking SSRI Antidepressants|
- International Index of Erectile Function (IIEF) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Sexual Function and Satisfaction Questionnaire (SFSQ) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Hamilton Depression Rating Scale, 17 items (HDRS-17) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Global Assessment of Functioning Scale (GAFS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Clinical Global Impressions (CGI) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- CGI-Sexual functioning (CGI-Sx) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Drug: Ropinirole (Requip)
A significant proportion of patients taking pharmacotherapy for treatment of depression experience sexual dysfunction at distressing levels, with reported rates varying considerably. When sexual dysfunction is assessed prospectively using structured questionnaires, high levels of dysfunction have been found. SSRIs including paroxetine, sertraline, and other medications, have been shown to have a similar frequency of sexual side effects and in a recent prospectively designed study 50% of men taking sertraline reported that they were only "slightly" (18%) or "not at all" (32%) satisfied with their sexual functioning. It is reported that sexual side effects of antidepressant treatment frequently result in noncompliance with and/or premature discontinuation of treatment. A recent study showed that the dopamine agonist Requip (Ropinirole) reduced the amount of SSRI-associated sexual dysfunction. The proposed study will utilize a placebo control group in a crossover design to determine the effect on sexual dysfunction of adding Requip (Requip CR formulation) to the patient's SSRI treatment.
30 patients experiencing sexual dysfunction attributable to SSRI treatment for depression will be entered into this study. All patients will receive 6 weeks of treatment with Ropinirole and 6 weeks with placebo in a crossover fashion. Assessments of sexual functioning and depression will be made at each visit.
|United States, New York|
|Mood Disorders Research Program|
|New York, New York, United States, 10019|
|Principal Investigator:||David J. Hellerstein, MD||St. Luke's Roosevelt Hospital Center and NY State Psychiatric Institute|