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Safety and Efficacy Study in Patients With Major Depressive Disorder

NCT00896363 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2018-03-19

Study results available
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Summary

The purpose of this study is to test if GSK163090 can reduce the symptoms of depression. The safety and how well the body can handle the drug will also be investigated. The study will be conducted in Russia in hospitalised patients with severe depression. GSK163090 will be compared with placebo, which looks like the study drug but does not contain any active substance. Subjects will be given either the study drug or the matching placebo.

Conditions

  • Depressive Disorder

Interventions

DRUG

GSK163090 1 mg

Developed for the treatment of Major Depressive Disorder

DRUG

GSK163090 Placebo

Developed for the treatment of Major Depressive Disorder

DRUG

GSK163090 3 mg

Developed for the treatment of Major Depressive Disorder

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-23
Primary Completion
2010-02-09
Completion
2010-02-09

Countries

  • Russia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00896363 on ClinicalTrials.gov