Depressive Disorder, Major, Major Depressive Disorder (MDD)
Conditions
Keywords
Major Depressive Disorder, Major Depression, Mood Disorders, Major Depressive Episode
Brief summary
This is a placebo-controlled, fixed dose study that will evaluate the efficacy and safety of GW679769 in subjects with major depressive disorder.
Interventions
DRUGGW679769
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
Yes
Inclusion criteria
* Subjects must have the ability to comprehend the key components of the consent form. * Subject must have met DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria for current MDE (major depressive episode) for at least 8 weeks prior to the Screening Visit. * If female, subjects must be practicing an acceptable method of birth control. * Subjects must have rating scores as outlined.
Exclusion criteria
* Subjects whose symptoms of the MDE are better accounted for by another diagnosis. * Subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder. * Subjects have a positive urine test for illicit drug use and/or a history of substance abuse or alcohol dependence within the past 12 months. * Subjects with an unstable medical disorder. * If female, pregnant or lactating. * Subjects who have received ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation) within the 6 months preceding screening or who have ever been homicidal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline on the 17-item Hamilton Depression Rating Scale (HAM-D) total score at week 8, Last Observation Carried Forward. | — |
Secondary
| Measure | Time frame |
|---|---|
| CGI, HAM-A, QUIDS, SDS, MOS-12 Sleep Module, LSEQ, Safety and Tolerability, PK/PD | — |
Countries
Canada, United States
Outcome results
None listed