Last updated: 11/07/2018 15:24:09

Effects of Antidepressants on Sexual Functioning

GSK study ID
AK130926
See study documents
Clinicaltrials.gov ID
NCT00051259
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Effects on Sexual Functioning of Extended-Release Bupropion Hydrochloride (300-450mg) and escitalopram (10-20mg) in Outpatients with Moderate to Severe Major Depression over an Eight-Week Treatment Period
Trial description: The purpose of this trial is to study the effects of two depression medications on sexual functioning.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Extended-Release Bupropion Hydrochloride
    • Enrollment:
    420
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Clayton A, Wightman D, Horrigan JP, Modell JG, Richard NE, Krishen A. A comparison of the effects on sexual functioning of bupropion XL, escitalopram and placebo in outpatients with major depression. 17th Annual US Psychiatric & Mental Health Congress, San Diego, CA, 18-21 November, 2004, Abstract No. 105
    Clayton AH, Croft H, Horrigan JP, Wightman DS, Krishen A, Richard NE, Modell JG. Bupropion XL compared with escitalopram: effects on sexual functioning and antidepressant efficacy in two randomized, double-blind, placebo-controlled studies. J Clin Psychiatry 2006; 67:736-746
    Medical condition
    Major Depressive Disorder (MDD)
    Product
    bupropion
    Collaborators
    Not applicable
    Study date(s)
    January 2003 to June 2004
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    no
    • Primary diagnosis of Major Depressive Disorder (MDD) with current duration lasting 12 weeks but no greater than 2 years.
    • Subjects must engage in sexual activity that leads to orgasm at least once every two weeks.
    • Subjects that have arousal or orgasm dysfunction.
    • Has previously failed to respond to two adequate trials of antidepressants in past 2 years.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Primary diagnosis of Major Depressive Disorder (MDD) with current duration lasting 12 weeks but no greater than 2 years.
    • Subjects must engage in sexual activity that leads to orgasm at least once every two weeks.
    • Subject must have normal orgasmic function and be willing to discuss with investigator.
    Exclusion criteria:
    • Subjects that have arousal or orgasm dysfunction.
    • Has previously failed to respond to two adequate trials of antidepressants in past 2 years.
    • Subject has other unstable medical disorders.
    • Subject has a positive urine test for illicit drug use at screening.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32216
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Oceanside, California, United States, 92056
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97210
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rockville, Maryland, United States, 20852
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New York, New York, United States, 10021
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 23 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2004-15-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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