Depressive Disorder, Major Clinical Trial
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
| Verified date | May 2017 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Effects of two depression medication on sexual functioning
| Status | Completed |
| Enrollment | 347 |
| Est. completion date | May 2005 |
| Est. primary completion date | May 2005 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | GSK Investigational Site | Austin | Texas |
| United States | GSK Investigational Site | Bellaire | Texas |
| United States | GSK Investigational Site | Beverly Hills | California |
| United States | GSK Investigational Site | Braintree | Massachusetts |
| United States | GSK Investigational Site | Brooklyn | New York |
| United States | GSK Investigational Site | Burbank | California |
| United States | GSK Investigational Site | Charleston | South Carolina |
| United States | GSK Investigational Site | Charlotte | North Carolina |
| United States | GSK Investigational Site | Charlottesville | Virginia |
| United States | GSK Investigational Site | Cleveland | Ohio |
| United States | GSK Investigational Site | Columbia | South Carolina |
| United States | GSK Investigational Site | Coral Springs | Florida |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Eugene | Oregon |
| United States | GSK Investigational Site | Fort Worth | Texas |
| United States | GSK Investigational Site | Greenfield | Massachusetts |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Jacksonville | Florida |
| United States | GSK Investigational Site | La Mesa | California |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Lincoln | Rhode Island |
| United States | GSK Investigational Site | Little Rock | Arkansas |
| United States | GSK Investigational Site | Marietta | Georgia |
| United States | GSK Investigational Site | Mesa | Arizona |
| United States | GSK Investigational Site | Middleton | Wisconsin |
| United States | GSK Investigational Site | Minneapolis | Minnesota |
| United States | GSK Investigational Site | New Orleans | Louisiana |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | Oak Brook | Illinois |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Rockville | Maryland |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Francisco | California |
| United States | GSK Investigational Site | Scottsdale | Arizona |
| United States | GSK Investigational Site | Smyrna | Georgia |
| United States | GSK Investigational Site | Temecula | California |
| United States | GSK Investigational Site | Toledo | Ohio |
| United States | GSK Investigational Site | Upland | California |
| United States | GSK Investigational Site | Walnut Creek | California |
| United States | GSK Investigational Site | Yakima | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Efficacy, Safety, Tolerability, Health Outcome |
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