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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00057226 |
Purpose
A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in Patients with Major Depressive Disorder (MDD)
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder (MDD) |
Drug: Radafaxine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Flexible-Dose Study Evaluating Efficacy, Safety, and Tolerability of Once-Daily Oral GW353162 (40-60mg) Versus Placebo in Subjects With Major Depressive Disorder Over an Eight-Week Treatment Period. |
| Estimated Enrollment: | 364 |
| Study Start Date: | March 2003 |
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 21 Study Locations| Study Director: | GSK Clinical Trials, M.D. | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | OHB20003 |
| Study First Received: | March 27, 2003 |
| Last Updated: | May 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00057226 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
GW353162, Major depressive disorder, flexible |
|
Pathologic Processes Disease Depression Mental Disorders |
Mood Disorders Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |