Effects of Antidepressants on Sexual Functioning

Phase 3CompletedNCT00051259

GlaxoSmithKline420 enrolled

Overview

The purpose of this trial is to study the effects of two depression medications on sexual functioning.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

420

Conditions

Major Depressive Disorder (MDD)

Interventions

Extended-Release Bupropion HydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (23)

GSK Investigational Site

Berkeley, California, United States

Outcomes

Primary Outcomes

Percentage of subjects with orgasm dysfunction. Change in HAMD-17 total score.

Secondary Outcomes

Percent of subjects in remission, HAMD-17. Changes in Sexual Functioning Questionnaire. Percent of responders, HAMD-17 CGI-I and CGI-S.

Data from ClinicalTrials.gov

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