Depressive Disorder
Conditions
Keywords
Flexible-dose, GSK372475, MDD, Venlafaxine XR, Major Depressive Disorder
Brief summary
To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects with Major Depressive Disorder (MDD)
Detailed description
A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/day to 2.0 mg/day) or Extended Release Venlafaxine XR (150 mg/day to 225 mg/day) Compared to Placebo in Adult Subjects Diagnosed with Major Depressive Disorder
Interventions
DRUGGSK372475
daily administration during the 10-week treatment phase
DRUGvenlafaxine
daily administration during the 10-week treatment phase
DRUGplacebo
daily administration during the 10-week treatment phase
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Major depressive episode (MDE) associated with Major Depressive Disorder (DSM-IV-TR criteria) * Duration of current episode is at least 12 weeks duration and less than 2 years * Symptoms of decreased energy, pleasure, and interest * Female subjects who agree to use acceptable methods of birth control throughout the study
Exclusion criteria
* Current diagnosis of Panic Disorder, or symptoms of generalized anxiety or panic attacks that could interfere with their ability to complete the trial * Symptoms of MDE better accounted for by another diagnosis * Diagnosis of Bipolar, schizophrenia, other psychotic disorder(s), borderline or antisocial personality disorder, or dementia. * Started psychotherapy within 3 months prior to the Screening * Received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening * Received psychoactive drugs within 4 weeks of randomization * Positive urine drug screen or positive blood alcohol * Suicidal risk or has had any previous suicide attempt, a family history of suicide attempt * Positive pregnancy test * History of seizure disorder, myocardial infarction (\< 1yr), or unstable medical condition * Failed to respond to an adequate course of pharmacotherapy of at least 2 different antidepressants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from randomization to the end of the Treatment Phase (Week 10) on a depression rating scale. | Randomisation (week 0) And end of the treatment |
Secondary
| Measure | Time frame |
|---|---|
| Endpoints related to response & remission on depression rating scales during time of treatment exposureChange during treatment & at endpoint-week 10:in Clinical Global Impression scale; in motivation, energy, & sexual functioning on patient-rated scales | Randomisation (week 0) and at weeks 1,2,4,6,8 and week 10 (end of treatment phase) |
Countries
Australia, Belgium, Bulgaria, Canada, Estonia, Finland, France, Germany, India, Poland, Slovakia, South Africa
Outcome results
None listed