Sexual Functioning Study With Antidepressants

Study Overview
=================
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

Official Title
-----------------
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

Conditions
-----------------
Depressive Disorder, Major, Major Depressive Disorder (MDD)

Intervention / Treatment
-----------------
* Drug: Bupropion Hydrochloride Extended-release
* Drug: Extended-release Venlafaxine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bupropion Hydrochloride Extended-release|nan|
|Drug: Extended-release Venlafaxine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy, Safety, Tolerability, Health Outcome |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sexual dysfunction, Depression, MDD