Effects of Antidepressants on Sexual Functioning

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00051259

Collaborator

(none)

420

Enrollment

Locations

Duration (Months)

18.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trial is to study the effects of two depression medications on sexual functioning.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder (MDD)	Drug: Extended-Release Bupropion Hydrochloride	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Jun 1, 2004

Actual Study Completion Date :

Jun 1, 2004

Outcome Measures

Primary Outcome Measures

Percentage of subjects with orgasm dysfunction. Change in HAMD-17 total score. []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Berkeley	California	United States	94709
2	GSK Investigational Site	Beverly Hills	California	United States	90210
3	GSK Investigational Site	La Mesa	California	United States	91942
4	GSK Investigational Site	Oceanside	California	United States	92056
5	GSK Investigational Site	Coral Springs	Florida	United States	33065
6	GSK Investigational Site	Jacksonville	Florida	United States	32216
7	GSK Investigational Site	Indianapolis	Indiana	United States	46202
8	GSK Investigational Site	Terre Haute	Indiana	United States	47802
9	GSK Investigational Site	Baltimore	Maryland	United States	21208
10	GSK Investigational Site	Rockville	Maryland	United States	20852
11	GSK Investigational Site	Minneapolis	Minnesota	United States	55454
12	GSK Investigational Site	New York	New York	United States	10021
13	GSK Investigational Site	Cleveland	Ohio	United States	44109
14	GSK Investigational Site	Toledo	Ohio	United States	43623
15	GSK Investigational Site	Tulsa	Oklahoma	United States	74135
16	GSK Investigational Site	Eugene	Oregon	United States	97401
17	GSK Investigational Site	Portland	Oregon	United States	97210
18	GSK Investigational Site	Lincoln	Rhode Island	United States	02865-4208
19	GSK Investigational Site	Charleston	South Carolina	United States	29407
20	GSK Investigational Site	Bellaire	Texas	United States	77401
21	GSK Investigational Site	Charlottesville	Virginia	United States	22908
22	GSK Investigational Site	Richmond	Virginia	United States	23294
23	GSK Investigational Site	Madison	Wisconsin	United States	53719