Treating Sexual Dysfunction From Selective Serotonin Reuptake Inhibitor (SSRI) Medication: a Stud… (NCT00334048) | Clinical Trial Compass
CompletedPhase 4
Treating Sexual Dysfunction From Selective Serotonin Reuptake Inhibitor (SSRI) Medication: a Study Comparing Requip CR to Placebo
United States9 participantsStarted 2006-06
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. male or female outpatients 18-65 years old
✓. 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
✓. Currently responding to the SSRI antidepressant treatment, as indicated by
✓. Meets DSM-IV criteria for Substance-Induced Sexual Dysfunction, with impairment of desire, arousal, or orgasm
✓. Are currently involved in an intimate relationship which includes sexual contact
✓. agree to use double-barrier contraception during sexual intercourse during the course of the study (women only)
✓. 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
✕. Patients with a DSM-IV diagnosis of Delirium, Dementia, and Amnestic, and other Cognitive Disorders,
✕. 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,
✕. Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol,
What they're measuring
1
International Index of Erectile Function (IIEF)
Timeframe: 6 weeks
2
Sexual Function and Satisfaction Questionnaire (SFSQ)
✕. Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following:
✕. 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.
✕. History of sexual dysfunction predating onset of depression and/or initiation of antidepressant therapy,
✕. Patients receiving any other treatment for sexual dysfunction, including sex therapy