NCT00057213CompletedPhase 2
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.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 367
- Locations
- 21
- Primary Endpoint
- Change in the Montgomery-Asberg Depression Rating Scale (MADRS) after 8 weeks of treatment
Study Overview
Brief Summary
A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in Patients with Major Depressive Disorder (MDD)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Major Depressive Disorder (MDD)
- •Duration of current depressive episode 12 weeks - 24 months
- •Patients can read and write at a level sufficient to provide a signed consent
- •If female, patients must be practicing an acceptable method of birth control
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) after 8 weeks of treatment
Time Frame: 8 Weeks
Secondary Outcomes
- 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;
Investigators
Study Sites (21)
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