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

Tracking Information

First Received Date ^ICMJE

October 28, 2002

Last Updated Date

August 8, 2007

Start Date ^ICMJE

November 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Hamilton Depression Rating Scale [ Time Frame: 8 Weeks ]

Original Primary Outcome Measures ^ICMJE

Hamiliton Depression Rating Scale

Change History

Complete list of historical versions of study NCT00048204 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale [ Time Frame: 8 Weeks ]

Original Secondary Outcome Measures ^ICMJE

Hamiliton Depression Rating Scale
Clinical Global Impression-Global Improvement
Clinical Global Impression-Severity of Illness
Hospital Anxiety and Depression Scale

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Fixed-Dose Study Comparing the Efficacy and Safety of GW597599B or Paroxetine to Placebo in Moderately to Severely Depressed Patients With Major Depressive Disorder

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Major Depressive Disorder

Intervention ^ICMJE

Drug: GW597599B
Drug: paroxetine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

372

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00048204

Responsible Party

Study ID Numbers ^ICMJE

NKD20006

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trial, MD, MPH

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

August 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP