Study Of GW679769 In Major Depressive Disorder

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a placebo-controlled, fixed dose study that will evaluate the efficacy and safety of GW679769 in subjects with major depressive disorder.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Casopitant

Criteria

Inclusion criteria:

• Subjects must have the ability to comprehend the key components of the consent form.

• Subject must have met DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria for current MDE (major depressive episode) for at least 8 weeks prior to the Screening Visit.

• If female, subjects must be practicing an acceptable method of birth control.

• Subjects must have rating scores as outlined.

Exclusion criteria:

• Subjects whose symptoms of the MDE are better accounted for by another diagnosis.

• Subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder.

• Subjects have a positive urine test for illicit drug use and/or a history of substance abuse or alcohol dependence within the past 12 months.

• Subjects with an unstable medical disorder.

• If female, pregnant or lactating.

• Subjects who have received ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation) within the 6 months preceding screening or who have ever been homicidal.