Sexual Functioning Study With Antidepressants

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Depressive Disorder, Major

Major Depressive Disorder (MDD)

Treatments

Drug: Extended-release Venlafaxine

Drug: Bupropion Hydrochloride Extended-release

Study type

Interventional

Funder types

Industry

Identifiers

NCT00316160

100368

Details and patient eligibility

About

Effects of two depression medication on sexual functioning

Full 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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.