Effects Of Antidepressants On Sexual Functioning In Adults

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder (MDD)

Treatments: Drug: Extended-release Bupropion Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00051272

AK130927

Details and patient eligibility

About

This study will evaluate the effects of two antidepression medications on sexual functioning.

Enrollment: 425 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary diagnosis of Major Depressive Disorder (MDD) with current duration lasting 12 weeks but no greater than 2 years.
• Subjects must engage in sexual activity that leads to orgasm at least once every two weeks.
• Subject must have normal orgasmic function and be willing to discuss with investigator.

Exclusion criteria

• Subjects that have arousal or orgasm dysfunction.
• Has previously failed to respond to two adequate trials of antidepressants in past 2 years.
• Subject has other unstable medical disorders.
• Subject has a positive urine test for illicit drug use at screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind