Clinical trial NCT00334048: Treating Sexual Dysfunction From Selective Serotonin Reuptake Inhibitor (SSRI) Medication: a Study Comparing Requip CR to Placebo
Official title: Treatment of Sexual Dysfunction Secondary to Antidepressant Pharmacotherapy: A Double-blind Comparison of Requip (Ropinirole) vs. Placebo in Patients Taking SSRI Antidepressants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sexual Dysfunction
Keywords: 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
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2006-06-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: International Index of Erectile Function (IIEF)
timeFrame: 6 weeks
measure: Sexual Function and Satisfaction Questionnaire (SFSQ)
timeFrame: 6 weeks
Secondary outcomes:
measure: Hamilton Depression Rating Scale, 17 items (HDRS-17)
timeFrame: 6 weeks
measure: Global Assessment of Functioning Scale (GAFS)
timeFrame: 6 weeks
measure: Clinical Global Impressions (CGI)
timeFrame: 6 weeks
measure: CGI-Sexual functioning (CGI-Sx)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Mood Disorders Research Program
state: New York
Study officials:
affiliation: St. Luke's Roosevelt Hospital Center and NY State Psychiatric Institute
name: David J. Hellerstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Worthington JJ 3rd, Simon NM, Korbly NB, Perlis RH, Pollack MH; Anxiety Disorders Research Program. Ropinirole for antidepressant-induced sexual dysfunction. Int Clin Psychopharmacol. 2002 Nov;17(6):307-10. doi: 10.1097/00004850-200211000-00006.
citation: Balon R. Sexual function and dysfunction during treatment with psychotropic medications. J Clin Psychiatry. 2005 Nov;66(11):1488-9. doi: 10.4088/jcp.v66n1120. No abstract available.