Last updated: 11/02/2018 22:54:14

Sexual Functioning Study With Antidepressants

GSK study ID
100368
See study documents
Clinicaltrials.gov ID
NCT00316160
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 Twelve-week, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group, Active controlled, Escalating Dose Study to Compare the Effects on Sexual Functioning of Bupropion Hydrochloride Extended-release (WELLBUTRIN XL, 150-450 mg/day) and Extended-release Venlafaxine (EFFEXOR XR, 75-225 mg/day) in Subjects with Major Depressive Disorder
Trial description: Effects of two depression medication 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: Bupropion Hydrochloride Extended-release
  • Drug: Extended-release Venlafaxine
    • Enrollment:
    347
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Thase ME, Clayton AH, Haight BR, Krishen A, Modell JG, A double-blind comparison between bupropion XL and venlafaxine XR: sexual functioning, antidepressant efficacy and tolerability. Journal of Neuropsychopharm 2006; 26 :482-488
    Medical condition
    Depressive Disorder, Major
    Product
    bupropion
    Collaborators
    Not applicable
    Study date(s)
    September 2004 to May 2005
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Primary diagnosis of Major Depressive Disorder (MDD)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Primary diagnosis of Major Depressive Disorder (MDD)
    • must have met DSM-IV criteria for current major depressive episode for at least 8 weeks but no long than 2 years.
    • HAM-D17 total score of >17 at screening and baseline.
    • Severity of illness score of >4 at screening and baseline.
    • Willing to discuss sexual functioning with investigator or designee.
    • Sexual activity that leads to orgasm at least every 2 weeks. Exclusion Criteria:
    • Past or current DSM-IV diagnosis of Bipolar Disorder I or II, schizophrenia or another psychotic disorder(s).
    • Primary DSM-IV diagnosis or received treatment for Panic Disorder, Obsessive Compulsive Disorder or Post Stress Disorder within previous 12 months.
    • Poses a homicidal or serious suicidal risk, have made an attempt within months prior to screening or who has ever been homicidal.
    • Myocardial infarction with 1 year of screening.
    • Taken ibupropion hydrochloride or venlafaxine in the last 6 months.
    • Positive urine test for illicit drug use or alcohol or substance abuse within the past 12 months.
    • Psychotherapy within 3 months.
    • Pregnant.
    • Electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior of screening.
    • ECG or clinical evidence of atrial or ventricular hypertrophy.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Smyrna, Georgia, United States, 30080
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Oak Brook, Illinois, United States, 60523
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Marietta, Georgia, United States, 30060
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85023
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Upland, California, United States, 91786
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
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    Showing 1 - 6 of 45 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
    2005-25-05

    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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