Last updated: 11/07/2018 15:24:09
Effects of Antidepressants on Sexual Functioning
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
Oceanside, California, United States, 92056
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97210
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Study Complete
Location
GSK Investigational Site
Rockville, Maryland, United States, 20852
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21208
Status
Study Complete
Location
GSK Investigational Site
Bellaire, Texas, United States, 77401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Terre Haute, Indiana, United States, 47802
Status
Study Complete
Location
GSK Investigational Site
Beverly Hills, California, United States, 90210
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53719
Status
Study Complete
Location
GSK Investigational Site
La Mesa, California, United States, 91942
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Study Complete
Location
GSK Investigational Site
Coral Springs, Florida, United States, 33065
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55454
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Rhode Island, United States, 02865-4208
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23294
Status
Study Complete
Location
GSK Investigational Site
Berkeley, California, United States, 94709
Status
Study Complete
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22908
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website