Last updated: 11/07/2018 15:24:23

Effects Of Antidepressants On Sexual Functioning In Adults

GSK study ID
AK130927
See study documents
Clinicaltrials.gov ID
NCT00051272
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: This study will evaluate the effects of two antidepression medications on sexual functioning.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Extended-release Bupropion Hydrochloride
    • Enrollment:
    425
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    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
    Wightman D, Horrigan JP, Modell JG, Richard NE, Krishen A. The Tolerability and Safety of Bupropion XL versus Escitalopram in the Treatment of Major Depressive Disorder. 13th Congress of the Association of European Psychiatrists (AEP), Munich, Germany, April 5, 2005. Abstract ID 4786.
    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
    Middletown, Connecticut, United States, 06457
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27609
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Washington, District of Columbia, United States, 20037
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Baton Rouge, Louisiana, United States, 70808
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berkeley, California, United States, 94709
    Status
    Terminated/Withdrawn
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    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
    2004-10-06

    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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