A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder

Phase 2

Completed

• Conditions: Depressive Disorder, Major

• Registration Number: NCT00048204
• Lead Sponsor: GlaxoSmithKline

Brief Summary

A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With Major Depressive Disorder (MDD)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-10-28
• Study First Submitted QC: 2002-10-29
• Study First Posted: 2002-10-30
• Study Start: 2002-11-04
• Primary Completion: 2003-09-30
• Study Completion: 2003-09-30
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 372

Inclusion Criteria

• Patients meet the diagnosis of Major Depressive Disorder (MDD).

Exclusion Criteria

• Patients with a primary diagnosis other than MDD.
• Patients with a history of schizophrenia, schizoaffective disorders, seizure disorders or bipolar affective disorder.
• Patients receiving formal psychotherapy or cognitive/behavioral therapy concurrently or in the 12 weeks prior to screening visit.
• Patient is actively suicidal.
• Patients who have a history of migraine headaches.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale	8 Weeks

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale	8 Weeks