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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00334048
First received: June 2, 2006
Last updated: October 15, 2008
Last verified: October 2008
  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
Drug: Ropinirole (Requip)
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 9
Study Start Date: June 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ropinirole (Requip)
    1 mg extended release formulation given once per day to a maximum of 4 per day
    Other Name: requip, ropinirole, requip XL
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334048

Locations
United States, New York
Mood Disorders Research Program
New York, New York, United States, 10019
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
GlaxoSmithKline
Investigators
Principal Investigator: David J. Hellerstein, MD St. Luke's Roosevelt Hospital Center and NY State Psychiatric Institute
  More Information

Additional Information:
Publications:
Responsible Party: David J. Hellerstein, MD, NY State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00334048     History of Changes
Other Study ID Numbers: 06-036, NYSPI IRB# 5185
Study First Received: June 2, 2006
Last Updated: October 15, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Medication-induced sexual dysfunction
SSRI-induced sexual dysfunction
Anorgasmia
Delayed ejaculation
Sexual dysfunction
Antidepressant-induced sexual dysfunction
Requip
Ropinirole
Dopamine agonist
Serotonin reuptake inhibitor
Sexual dysfunction, physiological, medication-induced

Additional relevant MeSH terms:
Antidepressive Agents
Ropinirole
Serotonin Uptake Inhibitors
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on September 14, 2014