Effects Of Antidepressants On Sexual Functioning In Adults

Phase 3CompletedNCT00051272

GlaxoSmithKline425 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

425

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 (24)

GSK Investigational Site

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Percent of subjects with orgasm dysfunction. Change from baseline in HAMD-17 total score.

Secondary Outcomes

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

Data from ClinicalTrials.gov

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