Treating Sexual Dysfunction From Selective Serotonin Reuptake Inhibitor (SSRI) Medication: a Study Comparing Requip CR to Placebo

February 18, 2015 updated by: St. Luke's-Roosevelt Hospital Center

Treatment of Sexual Dysfunction Secondary to Antidepressant Pharmacotherapy: A Double-blind Comparison of Requip (Ropinirole) vs. Placebo in Patients Taking SSRI Antidepressants

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • Mood Disorders Research Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. male or female outpatients 18-65 years old
  2. currently taking fluoxetine, sertraline, paroxetine, citalopram, or escitalopram at a stable dosage within the ranges specified for 1 month or longer required dosage range: (Prozac (fluoxetine) 20-80 mg/day; Celexa (citalopram) 20-60 mg/day; Lexapro (escitalopram) 10-30 mg/day; Zoloft (sertraline) 50-200 mg/day; Paxil (paroxetine) 20-60 mg/day; Paxil CR (paroxetine CR) 25-75 mg/day

  3. Currently responding to the SSRI antidepressant treatment, as indicated by

    • a score of 15 or less on the HDRS 24 item at screening and baseline, and (b) CGI-Severity score of 2 or less at baseline
  4. Meets DSM-IV criteria for Substance-Induced Sexual Dysfunction, with impairment of desire, arousal, or orgasm
  5. Are currently involved in an intimate relationship which includes sexual contact
  6. agree to use double-barrier contraception during sexual intercourse during the course of the study (women only)
  7. Agree to the study team contacting the physician who prescribe their SSRI medication to inform them of their participation in the current study

Exclusion Criteria:

  1. Patients with a DSM-IV diagnosis of Delirium, Dementia, and Amnestic, and other Cognitive Disorders,
  2. Patients with a principal diagnosis meeting DSM-IV criteria for: Bipolar Disorder or cyclothymia, Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders Not Otherwise Specified, or Anorexia Nervosa or Bulimia,
  3. Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol,

  4. Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following:

    • report of having a specific plan for killing themselves,
    • a score of 3 or higher on the Hamilton Depression Rating Scale item 3 as rated by the study doctor at the first visit, (indicative of active suicidal thoughts or behaviors), or
    • a suicide attempt within the past 6 months,
  5. Patients with a history of medical conditions or procedures which may cause sexual dysfunction, including: peripheral vascular disease, radical prostatectomy, trans-urethral resection of the prostate [TURP], or spinal cord injury.
  6. History of sexual dysfunction predating onset of depression and/or initiation of antidepressant therapy,
  7. Patients receiving any other treatment for sexual dysfunction, including sex therapy
  8. Pregnant or nursing women.
  9. Patients with unstable or life-threatening medical conditions, such as uncontrolled hypertension, diabetes, or hypothyroidism, acute infections, pneumonia, severe renal or hepatic impairment.
  10. Patients with any the following: retinal disease, sleep apnea, or narcolepsy.
  11. Patients taking dopamine agonist medication.

  12. Patients taking medications that are

    • associated with orthostatic hypotension, such as tricyclic antidepressants, MAO Inhibitors, and alpha1 antagonists
    • CYP1A2 inhibitors, such as fluoroquinolones, fluvoxamine, cimetidine
    • SSRI medication used cyclically for PMDD
  13. Patients who do not expect to have regular sexual contact with another person over the next 13 weeks.
  14. Patients with a DSM-IV diagnosis of Pathological Gambling

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
International Index of Erectile Function (IIEF)
Time Frame: 6 weeks
6 weeks
Sexual Function and Satisfaction Questionnaire (SFSQ)
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Hamilton Depression Rating Scale, 17 items (HDRS-17)
Time Frame: 6 weeks
6 weeks
Global Assessment of Functioning Scale (GAFS)
Time Frame: 6 weeks
6 weeks
Clinical Global Impressions (CGI)
Time Frame: 6 weeks
6 weeks
CGI-Sexual functioning (CGI-Sx)
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's-Roosevelt Hospital Center

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: David J. Hellerstein, MD, St. Luke's Roosevelt Hospital Center and NY State Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

June 2, 2006

First Submitted That Met QC Criteria

June 2, 2006

First Posted (Estimate)

June 6, 2006

Study Record Updates

Last Update Posted (Estimate)

February 19, 2015

Last Update Submitted That Met QC Criteria

February 18, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-036
  • NYSPI IRB# 5185

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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