Status:
COMPLETED
MDD POC Study GSK372475 Subjects Depressive Disease
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 outpatients subjects with major depressive disorder to exhibit decreased pleasure, interest and...
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 panic disorder / attacks, generalised anxiety, borderline or antisocial personality disorder, dementia, anorexia nervosa / bulimia (within 6 months of screening), bipolar disorder, schizophrenia or any other psychotic disorder(s).
- 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 :
December 19 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2008
Estimated Enrollment :
492 Patients enrolled
Trial Details
Trial ID
NCT00420641
Start Date
December 19 2006
End Date
October 15 2008
Last Update
February 5 2018
Active Locations (33)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Plovdiv, Bulgaria, 4000
2
GSK Investigational Site
Sofia, Bulgaria, 1000
3
GSK Investigational Site
Miramichi, New Brunswick, Canada, E1V 3G5
4
GSK Investigational Site
Burlington, Ontario, Canada, L7R 4E2