Sexual Functioning Study With Antidepressants

Completed · Phase 4

Conditions studied: Depressive Disorder, Major, Major Depressive Disorder (MDD)

In brief

Effects of two depression medication on sexual functioning

Key facts

Study ID

NCT00316160

Run by

GlaxoSmithKline

People needed

347

Starts

2004-09-01

Expected to finish

2005-05-01

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Mesa, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Beverly Hills, California, United States
• GSK Investigational Site — Burbank, California, United States
• GSK Investigational Site — La Mesa, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Temecula, California, United States
• GSK Investigational Site — Upland, California, United States
• GSK Investigational Site — Walnut Creek, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Coral Springs, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Marietta, Georgia, United States
• GSK Investigational Site — Smyrna, Georgia, United States
• GSK Investigational Site — Oak Brook, Illinois, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — New Orleans, Louisiana, United States
• GSK Investigational Site — Rockville, Maryland, United States
• GSK Investigational Site — Braintree, Massachusetts, United States
• GSK Investigational Site — Greenfield, Massachusetts, United States
• GSK Investigational Site — Minneapolis, Minnesota, United States
• GSK Investigational Site — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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