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”

Effects of two depression medication on sexual functioning

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Bupropion Hydrochloride Extended-release
• Drug: Extended-release Venlafaxine

Primary Measures

• 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 Measures

• Efficacy, Safety, Tolerability, Health Outcome

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trial, MD Study Chair GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00316160

Study ID Number: 100368

ClinicalTrials.gov Identifier: NCT00316160

Health Authority: United States: Food and Drug Administration