search
Back to results

Effects Of Antidepressants On Sexual Functioning In Adults

Primary Purpose

Major Depressive Disorder (MDD)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Extended-release Bupropion Hydrochloride
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder (MDD) focused on measuring depression, sexual dysfunction, orgasm disorder, MDD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Percent of subjects with orgasm dysfunction. Change from baseline in HAMD-17 total score.

Secondary Outcome Measures

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

Full Information

First Posted
January 7, 2003
Last Updated
March 28, 2011
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00051272
Brief Title
Effects Of Antidepressants On Sexual Functioning In Adults
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 Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
This study will evaluate the effects of two antidepression medications on sexual functioning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder (MDD)
Keywords
depression, sexual dysfunction, orgasm disorder, MDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
425 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Extended-release Bupropion Hydrochloride
Primary Outcome Measure Information:
Title
Percent of subjects with orgasm dysfunction. Change from baseline in HAMD-17 total score.
Secondary Outcome Measure Information:
Title
Percent of subjects in remission, HAMD-17. Changes in Sexual functioning Questionnaire. CGI-I and CGI-S. Percent of responders, HAMD-17.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
GSK Investigational Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
GSK Investigational Site
City
Berkeley
State/Province
California
ZIP/Postal Code
94709
Country
United States
Facility Name
GSK Investigational Site
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Facility Name
GSK Investigational Site
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19808
Country
United States
Facility Name
GSK Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
GSK Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
GSK Investigational Site
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
GSK Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
GSK Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
GSK Investigational Site
City
Braintree
State/Province
Massachusetts
ZIP/Postal Code
02184
Country
United States
Facility Name
GSK Investigational Site
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
GSK Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
GSK Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
GSK Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
GSK Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
GSK Investigational Site
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3815
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
GSK Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
GSK Investigational Site
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effects Of Antidepressants On Sexual Functioning In Adults

We'll reach out to this number within 24 hrs