Study Of The Effects Of A New Antidepressant Therapy In Patients With Major Depressive Disorder (MDD)

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Depressive Disorder, Major

Treatments

Drug: GW679769

Study type

Interventional

Funder types

Industry

Identifiers

NKF100096

Details and patient eligibility

About

The purpose of this study is to assess the efficacy, safety and tolerability of GW679769 patients with Major depressive Disorder (MDD).

Enrollment

348 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Primary diagnosis of Major depressive Disorder as defined in DSM-IV.
Capable of giving informed consent and willing to comply with the study requirements.
Women of childbearing potential must agree to one of a number of defined acceptable methods of birth control.

Exclusion criteria

Primary diagnosis within the past 6 months of another Axis 1 disorder such as an anxiety disorder.
Use of medications for a psychiatric condition including herbals in the past 2-12 weeks according to medication type.
Subjects who, in the investigator's judgement, pose a current, serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months.
Subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance abuse or subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance dependence (other than nicotine).
Significantly abnormal blood or urine laboratory tests or electrocardiogram (ECG).