Sexual Functioning Study With Antidepressants

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Effects of two depression medication on sexual functioning

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Bupropion; Venlafaxine Hydrochloride

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.