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| Sponsors and Collaborators: |
St. Luke's-Roosevelt Hospital Center GlaxoSmithKline |
| Information provided by: | St. Luke's-Roosevelt Hospital Center |
| ClinicalTrials.gov Identifier: | NCT00334048 |
Purpose
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.
| Condition | Intervention | Phase |
|
Sexual Dysfunction, Physiological, Medication-Induced |
Drug: Ropinirole (Requip) |
Phase IV |
| MedlinePlus related topics: | Antidepressants |
| ChemIDplus related topics: | Ropinirole Ropinirole hydrochloride Dopamine Dopamine hydrochloride Serotonin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | Treatment of Sexual Dysfunction Secondary to Antidepressant Pharmacotherapy: A Double-Blind Comparison of Requip (Ropinirole) vs. Placebo in Patients Taking SSRI Antidepressants |
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | September 2007 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Currently responding to the SSRI antidepressant treatment, as indicated by
Exclusion Criteria:
Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following:
Patients taking medications that are
Contacts and Locations| United States, New York | |||||
| Mood Disorders Research Program | |||||
| New York, New York, United States, 10019 | |||||
| St. Luke's-Roosevelt Hospital Center |
| GlaxoSmithKline |
| Principal Investigator: | David J. Hellerstein, MD | St. Luke's Roosevelt Hospital Center and NY State Psychiatric Institute |
More Information
Mood Disorders Research Program website 
  |
Columbia Psychiatry website 
  |
| Study ID Numbers: | 06-036, NYSPI IRB# 5185 |
| First Received: | June 2, 2006 |
| Last Updated: | July 18, 2007 |
| ClinicalTrials.gov Identifier: | NCT00334048 |
| Health Authority: | United States: Institutional Review Board |
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