NCT00334048

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

February 19, 2015

Status Verified

February 1, 2015

Enrollment Period

1.3 years

First QC Date

June 2, 2006

Last Update Submit

February 18, 2015

Conditions

Sexual Dysfunction

Keywords

Medication-induced sexual dysfunctionSSRI-induced sexual dysfunctionAnorgasmiaDelayed ejaculationSexual dysfunctionAntidepressant-induced sexual dysfunctionRequipRopiniroleDopamine agonistSerotonin reuptake inhibitorSexual dysfunction, physiological, medication-induced

Outcome Measures

Primary Outcomes (2)

  • International Index of Erectile Function (IIEF)

    6 weeks

  • Sexual Function and Satisfaction Questionnaire (SFSQ)

    6 weeks

Secondary Outcomes (4)

  • Hamilton Depression Rating Scale, 17 items (HDRS-17)

    6 weeks

  • Global Assessment of Functioning Scale (GAFS)

    6 weeks

  • Clinical Global Impressions (CGI)

    6 weeks

  • CGI-Sexual functioning (CGI-Sx)

    6 weeks

Interventions

Ropinirole (Requip)DRUG

1 mg extended release formulation given once per day to a maximum of 4 per day

Also known as: requip, ropinirole, requip XL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • 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

You may not qualify if:

  • 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,
  • 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,
  • 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
  • Pregnant or nursing women.
  • Patients with unstable or life-threatening medical conditions, such as uncontrolled hypertension, diabetes, or hypothyroidism, acute infections, pneumonia, severe renal or hepatic impairment.
  • Patients with any the following: retinal disease, sleep apnea, or narcolepsy.
  • Patients taking dopamine agonist medication.
  • Patients taking medications that are
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mood Disorders Research Program

New York, New York, 10019, United States

Location

Related Publications (2)

  • 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.

    PMID: 12409684BACKGROUND

  • 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.

    PMID: 16420088BACKGROUND

Related Links

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalEjaculatory Dysfunction

Interventions

ropinirole

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, MaleMale Urogenital Diseases

Study Officials

  • David J. Hellerstein, MD

    St. Luke's Roosevelt Hospital Center and NY State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 6, 2006

Study Start

June 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

February 19, 2015

Record last verified: 2015-02

Locations

US(1)