Sexual Functioning Study With Antidepressants
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
1 other identifier
interventional
347
1 country
45
Brief Summary
Effects of two depression medication on sexual functioning
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2004
Shorter than P25 for phase_4
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 18, 2006
CompletedFirst Posted
Study publicly available on registry
April 20, 2006
CompletedMay 30, 2017
May 1, 2017
8 months
April 18, 2006
May 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the effects of bupropion XL and venlafaxine XR on overall sexual functioning in outpatients with MDD as measured by mean changes in CSFQ-S total scores across Weeks 5, 6, 9 and 12.
Secondary Outcomes (1)
Efficacy, Safety, Tolerability, Health Outcome
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (45)
GSK Investigational Site
Mesa, Arizona, 85210, United States
GSK Investigational Site
Phoenix, Arizona, 85023, United States
GSK Investigational Site
Scottsdale, Arizona, 85251, United States
GSK Investigational Site
Little Rock, Arkansas, 72223, United States
GSK Investigational Site
Beverly Hills, California, 90210, United States
GSK Investigational Site
Burbank, California, 91506, United States
GSK Investigational Site
La Mesa, California, 91942, United States
GSK Investigational Site
San Francisco, California, 94109, United States
GSK Investigational Site
Temecula, California, 92591, United States
GSK Investigational Site
Upland, California, 91786, United States
GSK Investigational Site
Walnut Creek, California, 94598, United States
GSK Investigational Site
Denver, Colorado, 80212, United States
GSK Investigational Site
Coral Springs, Florida, 33065, United States
GSK Investigational Site
Jacksonville, Florida, 32216, United States
GSK Investigational Site
Orlando, Florida, 32806, United States
GSK Investigational Site
Marietta, Georgia, 30060, United States
GSK Investigational Site
Smyrna, Georgia, 30080, United States
GSK Investigational Site
Oak Brook, Illinois, 60523, United States
GSK Investigational Site
Indianapolis, Indiana, 46202, United States
GSK Investigational Site
New Orleans, Louisiana, 70112, United States
GSK Investigational Site
Rockville, Maryland, 20852, United States
GSK Investigational Site
Braintree, Massachusetts, 02184, United States
GSK Investigational Site
Greenfield, Massachusetts, 01301, United States
GSK Investigational Site
Minneapolis, Minnesota, 55454, United States
GSK Investigational Site
Las Vegas, Nevada, 89146, United States
GSK Investigational Site
Brooklyn, New York, 11235, United States
GSK Investigational Site
New York, New York, 10128, United States
GSK Investigational Site
Charlotte, North Carolina, 28209, United States
GSK Investigational Site
Cleveland, Ohio, 44109, United States
GSK Investigational Site
Toledo, Ohio, 43623, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73117, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Portland, Oregon, 97209, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Lincoln, Rhode Island, 02865-4208, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Columbia, South Carolina, 29201, United States
GSK Investigational Site
Austin, Texas, 78756, United States
GSK Investigational Site
Bellaire, Texas, 77401, United States
GSK Investigational Site
Fort Worth, Texas, 76107, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Charlottesville, Virginia, 22908, United States
GSK Investigational Site
Yakima, Washington, 98902, United States
GSK Investigational Site
Middleton, Wisconsin, 53562-2215, United States
Related Publications (1)
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.
PMID: 16974189RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2006
First Posted
April 20, 2006
Study Start
September 1, 2004
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
May 30, 2017
Record last verified: 2017-05