Status:
COMPLETED
Clinical Study to Test a New Drug to Treat Major Depression
Lead Sponsor:
GlaxoSmithKline
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
In this randomized, double-blind, multi-centre, placebo controlled, exploratory, adaptive design study, the antidepressant and plasma cytokine lowering effects of the GW856553 will be investigated in ...
Eligibility Criteria
Inclusion
- Key
- Adult subjects with primary diagnosis of moderate to severe MDD without psychotic features, for at least 4 weeks and one previous MDD episode
- Males or Females who agree to use protocol specified contraception if of child bearing potential
- BMI 18.5-35.0 kg/m2
- Normal liver function tests
- Key
Exclusion
- History of liver disease or positive hepatitis B surface antigen or hepatitis C antibody in the last 3 months
- Elevated liver function tests on \>2 ocassions in the last 7 months
- Significant medical illness, autoimmune disease or infectious disease
- Pregnant or nursing females
- Excessive and regular alcohol consumption
- History of substance abuse or dependence in past 6 months or positive urine drug screen
- Significant suicidal or homicidal risk
- Currently receiving chronic biological or pharmacologic anti-inflammatory therapy or is not euthyroid
- Psychoactive drugs within 1 week or 5 half lives of randomization visit
- Treatment resistant subjects
Key Trial Info
Start Date :
September 25 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2010
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00976560
Start Date
September 25 2009
End Date
July 7 2010
Last Update
November 14 2017
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Hoffman Estates, Illinois, United States, 60169
2
GSK Investigational Site
Park Ridge, Illinois, United States, 60068
3
GSK Investigational Site
New York, New York, United States, 10128
4
GSK Investigational Site
Columbus, Ohio, United States, 43210