Status:
COMPLETED
A Study Of New Medicine (GSK 372475) For The Treatment Of Depression
Lead Sponsor:
GlaxoSmithKline
Conditions:
Depressive Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT00448058
Start Date
April 1 2007
End Date
December 1 2008
Last Update
October 10 2014
Active Locations (42)
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1
GSK Investigational Site
Auchenflower, Queensland, Australia, 4066
2
GSK Investigational Site
Kippa-Ring, Queensland, Australia, 4021
3
GSK Investigational Site
Epping, Victoria, Australia, 3076
4
GSK Investigational Site
Heidelberg West, Victoria, Australia, 3081