NCT00316160CompletedPhase 4
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 347
- Locations
- 45
- Primary Endpoint
- 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.
Study Overview
Brief Summary
Effects of two depression medication on sexual functioning
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
- Efficacy, Safety, Tolerability, Health Outcome
Investigators
Study Sites (45)
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