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Sexual DysfunctionPhase 4NCT00334048

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

A Phase 4 study testing Ropinirole (Requip) in people with Sexual Dysfunction, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Sexual Dysfunction
What is being tested?
Ropinirole (Requip)
How many people
9 participants
Where
1 siteUnited States
Study dates
Jun 2006to Sep 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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
  • 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
  • Patients who do not expect to have regular sexual contact with another person over the next 13 weeks.
  • Patients with a DSM-IV diagnosis of Pathological Gambling

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mood Disorders Research Program

    New York, New York, 10019

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Ropinirole (Requip)
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
Medical subject headings
Sexual Dysfunction, Physiological, Ejaculatory Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropinirole (Requip)Drug

    Also called requip, ropinirole, requip XL

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. International Index of Erectile Function (IIEF)

    Measured: 6 weeks

  2. Sexual Function and Satisfaction Questionnaire (SFSQ)

    Measured: 6 weeks

Secondary outcomes (4)

  1. Hamilton Depression Rating Scale, 17 items (HDRS-17)

    Measured: 6 weeks

  2. Global Assessment of Functioning Scale (GAFS)

    Measured: 6 weeks

  3. Clinical Global Impressions (CGI)

    Measured: 6 weeks

  4. CGI-Sexual functioning (CGI-Sx)

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionSep 2007
  4. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00334048
Sponsor's protocol ID
06-036
Other IDs
NYSPI IRB# 5185
Status last verified
Feb 2015
First submitted
2 Jun 2006
Last updated
19 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12409684

  • 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.

    PubMed 16420088

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ropinirole (Requip) in people with Sexual Dysfunction, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Index of Erectile Function (IIEF) (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00334048, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2015.

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