An 8 Week Study Of Adults Diagnosed With Major Depressive Disorder
Phase 2
Completed
- Conditions
- Depressive Disorder, Major
- Registration Number
- NCT00057226
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in Patients with Major Depressive Disorder (MDD)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 365
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in the Montgomery-Asberg Depression Rating Scale (MADRS) score after 8 weeks of treatment 8 Weeks
- Secondary Outcome Measures
Name Time Method Change in the MADRS score at other timepoints; change in the Global Impression; percentage of remitters and responders based on the MADRS; change in anxiety, disability, motivation, energy, fatigue and pain; incidence of adverse events during the study
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Bellevue, Washington, United States