NCT00051272

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
425

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2003

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

March 29, 2011

Status Verified

March 1, 2011

Enrollment Period

1.4 years

First QC Date

January 7, 2003

Last Update Submit

March 28, 2011

Conditions

Major Depressive Disorder (MDD)

Keywords

depression, sexual dysfunction, orgasm disorder, MDD

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Extended-release Bupropion HydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

GSK Investigational Site

Phoenix, Arizona, 85015, United States

Location

GSK Investigational Site

Scottsdale, Arizona, 85251, United States

Location

GSK Investigational Site

Berkeley, California, 94709, United States

Location

GSK Investigational Site

Middletown, Connecticut, 06457, United States

Location

GSK Investigational Site

Wilmington, Delaware, 19808, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20037, United States

Location

GSK Investigational Site

Orlando, Florida, 32806, United States

Location

GSK Investigational Site

Marietta, Georgia, 30060, United States

Location

GSK Investigational Site

Smyrna, Georgia, 30080, United States

Location

GSK Investigational Site

Boise, Idaho, 83702, United States

Location

GSK Investigational Site

Baton Rouge, Louisiana, 70808, United States

Location

GSK Investigational Site

Braintree, Massachusetts, 02184, United States

Location

GSK Investigational Site

Piscataway, New Jersey, 08854, United States

Location

GSK Investigational Site

New York, New York, 10128, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27609, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44106, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73118, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37203, United States

Location

GSK Investigational Site

Bellaire, Texas, 77401, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229-3815, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

San Antonio, Texas, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84107, United States

Location

GSK Investigational Site

Yakima, Washington, 98902, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepressionSexual Dysfunction, PhysiologicalSexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehaviorGenital DiseasesUrogenital Diseases

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 7, 2003

First Posted

January 8, 2003

Study Start

January 1, 2003

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

March 29, 2011

Record last verified: 2011-03

Locations

US(24)