Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
347 participants
INTERVENTIONAL
2004-09-30
2005-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Bupropion Hydrochloride Extended-release
Extended-release Venlafaxine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Mesa, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Scottsdale, Arizona, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Beverly Hills, California, United States
GSK Investigational Site
Burbank, California, United States
GSK Investigational Site
La Mesa, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Temecula, California, United States
GSK Investigational Site
Upland, California, United States
GSK Investigational Site
Walnut Creek, California, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Coral Springs, Florida, United States
GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Marietta, Georgia, United States
GSK Investigational Site
Smyrna, Georgia, United States
GSK Investigational Site
Oak Brook, Illinois, United States
GSK Investigational Site
Indianapolis, Indiana, United States
GSK Investigational Site
New Orleans, Louisiana, United States
GSK Investigational Site
Rockville, Maryland, United States
GSK Investigational Site
Braintree, Massachusetts, United States
GSK Investigational Site
Greenfield, Massachusetts, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Brooklyn, New York, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Toledo, Ohio, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Eugene, Oregon, United States
GSK Investigational Site
Portland, Oregon, United States
GSK Investigational Site
Portland, Oregon, United States
GSK Investigational Site
Lincoln, Rhode Island, United States
GSK Investigational Site
Charleston, South Carolina, United States
GSK Investigational Site
Columbia, South Carolina, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Bellaire, Texas, United States
GSK Investigational Site
Fort Worth, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Charlottesville, Virginia, United States
GSK Investigational Site
Yakima, Washington, United States
GSK Investigational Site
Middleton, Wisconsin, United States
Countries
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References
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Thase ME, Clayton AH, Haight BR, Thompson AH, Modell JG, Johnston JA. A double-blind comparison between bupropion XL and venlafaxine XR: sexual functioning, antidepressant efficacy, and tolerability. J Clin Psychopharmacol. 2006 Oct;26(5):482-8. doi: 10.1097/01.jcp.0000239790.83707.ab.
Other Identifiers
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100368
Identifier Type: -
Identifier Source: org_study_id
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