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OpenTrials
Completed

NCT Number: NCT00051259

Effects of Antidepressants on Sexual Functioning

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

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Key information

Conditions

Major Depressive Disorder (MDD) Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Genital Diseases Mental Disorders Mood Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Berkeley, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extended-release Bupropion Hydrochloride

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jan 8, 2003
Registry last updated
Oct 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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