Depressive Disorder, Major
Conditions
Keywords
Major Depressive Disorder (MDD),, Flexible, GW353162,
Brief summary
A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in Patients with Major Depressive Disorder (MDD)
Interventions
DRUGRadafaxine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) after 8 weeks of treatment | 8 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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; | — |
Countries
United States
Outcome results
None listed