Depressive Disorder, Major, Major Depressive Disorder (MDD)
Conditions
Keywords
sexual dysfunction, Depression, MDD
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 Extended-release (WELLBUTRIN XL, 150-450 mg/day) and Extended-release Venlafaxine (EFFEXOR XR, 75-225 mg/day) in Subjects with Major Depressive Disorder
Interventions
DRUGExtended-release Venlafaxine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effects of bupropion XL and venlafaxine XR on overall sexual functioning in outpatients with MDD as measured by mean changes in CSFQ-S total scores across Weeks 5, 6, 9 and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy, Safety, Tolerability, Health Outcome | — |
Countries
United States
Outcome results
None listed