Study Of GW679769 In Major Depressive Disorder

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Depressive Disorder, Major

Major Depressive Disorder (MDD)

Treatments

Drug: GW679769

Study type

Interventional

Funder types

Industry

Identifiers

NKF100092

Details and patient eligibility

About

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

Enrollment

356 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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.