A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Flexible-Dose Study Evaluating Efficacy, Safety, and Tolerability of Once-Daily Oral GW353162 (20-40-60mg) Versus Placebo in Subjects With Major Depressive Disorder Over an Eight-Week Treatment Period.

GlaxoSmithKline1 site in 1 country367 target enrollmentMarch 2003

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Depressive Disorder, Major
Sponsor: GlaxoSmithKline
Enrollment: 367
Locations: 1
Primary Endpoint: Change in the Montgomery-Asberg Depression Rating Scale (MADRS) after 8 weeks of treatment
Status: Completed
Last Updated: 11 years ago

A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in Patients with Major Depressive Disorder (MDD)

Registry

clinicaltrials.gov

Start Date

March 2003

End Date

April 2007

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Patients have other psychiatric disorders that would affect patient's response to treatment
•Patients have not responded to two or more adequate courses of antidepressant therapy
•Patients cannot be currently abusing illicit drugs or alcohol
•Patients are not currently receiving psychotherapy
•Patients have received electroconvulsive therapy within 6 months prior to screening
•Patients are pregnant or lactating

Change in the Montgomery-Asberg Depression Rating Scale (MADRS) after 8 weeks of treatment

Time Frame: 8 Weeks

Change in the MADRS score at other timepoints; change in Clinical Global Impression; percentage of remitters and responders based on the MADRS; change in disability, motivation, energy, fatigue and pain;incidence of adverse events over course of study;