Sexual Functioning Study With Antidepressants

Condition(s) targeted: Major Depressive Disorder

Intervention: Bupropion Hydrochloride Extended-release (Drug); Extended-release Venlafaxine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Chair, Affiliation: GlaxoSmithKline

Effects of two depression medication on sexual functioning

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

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

Primary outcome: 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 outcome: Efficacy, Safety, Tolerability, Health Outcome

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

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Starting date: August 2004
Last updated: January 14, 2008