Last updated: 11/02/2018 22:54:14
Sexual Functioning Study With Antidepressants
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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:
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
- 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.
- 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.
Inclusion and exclusion 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
GSK Investigational Site
Oak Brook, Illinois, United States, 60523
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30060
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85023
Status
Study Complete
Location
GSK Investigational Site
Upland, California, United States, 91786
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Coral Springs, Florida, United States, 33065
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
Status
Study Complete
Location
GSK Investigational Site
Burbank, California, United States, 91506
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Rhode Island, United States, 02865-4208
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97210
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Study Complete
Location
GSK Investigational Site
Greenfield, Massachusetts, United States, 01301
Status
Study Complete
Location
GSK Investigational Site
La Mesa, California, United States, 91942
Status
Study Complete
Location
GSK Investigational Site
Temecula, California, United States, 92591
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94598
Status
Study Complete
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22908
Status
Study Complete
Location
GSK Investigational Site
Yakima, Washington, United States, 98902
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94109
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89146
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10128
Status
Study Complete
Location
GSK Investigational Site
Rockville, Maryland, United States, 20852
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Middleton, Wisconsin, United States, 53562-2215
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73117
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80212
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72223
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32806
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97209
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55454
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
Status
Study Complete
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70112
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, New York, United States, 11235
Status
Study Complete
Location
GSK Investigational Site
Braintree, Massachusetts, United States, 02184
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76107
Status
Study Complete
Location
GSK Investigational Site
Beverly Hills, California, United States, 90210
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
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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Access to clinical trial data by researchers
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