NCT00051272CompletedPhase 3
A Multicenter, Double-blind Randomized Placebo-controlled Comparison of the Effects on Sexual Functioning of Extended-release Bupropion Hydrochloride (300-450mg) and Escitalopram (10-20mg) in Outpatients With Moderate to Severe Major Depression Over an Eight-Week Treatment Period
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 425
- Locations
- 24
- Primary Endpoint
- Percent of subjects with orgasm dysfunction. Change from baseline in HAMD-17 total score.
Study Overview
Brief Summary
This study will evaluate the effects of two antidepression medications on sexual functioning.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Investigators
Study Sites (24)
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