Status:
COMPLETED
Sexual Functioning Study With Antidepressants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Depressive Disorder, Major
Major Depressive Disorder (MDD)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Effects of two depression medication on sexual functioning
Detailed Description
A Twelve-week, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group, Active controlled, Escalating Dose Study to Compare the Effects on Sexual Functioning of Bupropion Hydrochloride Ex...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT00316160
Start Date
September 1 2004
End Date
May 1 2005
Last Update
May 30 2017
Active Locations (45)
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1
GSK Investigational Site
Mesa, Arizona, United States, 85210
2
GSK Investigational Site
Phoenix, Arizona, United States, 85023
3
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
4
GSK Investigational Site
Little Rock, Arkansas, United States, 72223