Status:
COMPLETED
A Efficacy Study of PRX-00023 in Patients With Major Depressive Disorder
Lead Sponsor:
Epix Pharmaceuticals, Inc.
Conditions:
Major Depressive Disorder (MDD)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this randomized, double-blind, placebo-controlled study is to assess the safety and efficacy of PRX-00023 in patients with major depressive disorder.
Detailed Description
Patients with major depressive disorder who meet all of the eligibility criteria will be randomly assigned to receive twice daily doses of either placebo or PRX-00023. Study drug will be taken for up ...
Eligibility Criteria
Inclusion
- Key
- Diagnosis of major depressive disorder
- Key
Exclusion
- Females who are pregnant or nursing
- Electroconvulsive therapy within previous year
- Type 1 diabetes or uncontrolled type 2 diabetes
- HIV, Hepatitis B or Hepatitis C
- Use of illegal drugs, history of drug abuse, and/or alcohol dependence
- Clinically significant abnormal lab results
- Other protocol-defined eligibility criteria may apply.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00448292
Start Date
March 1 2007
End Date
November 1 2007
Last Update
November 14 2007
Active Locations (21)
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1
Vista Medical Research, Inc.
Mesa, Arizona, United States, 85206
2
Pharmacology Research Institute
Encino, California, United States, 91316
3
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
4
Synergy Clinical Research Center
National City, California, United States, 91950