Multicentre Trial to Evaluate the Safety and Efficacy of CP-316,311 in Major Depressive Disorder
Phase 2
Terminated
- Conditions
- Depressive Disorder, Major
- Registration Number
- NCT00143091
- Lead Sponsor
- Pfizer
- Brief Summary
A six week, fixed dose, double-blind, double-dummy, placebo, and active controlled, multicentre trial to evaluate the safety and efficacy of CP-316,311 in outpatients with major depressive disorder.
- Detailed Description
This study was terminated on March 17th, 2006. The results of the primary analysis at the interim showed that the CP-316,311 group was not significantly different than the placebo on the primary endpoint and therefore the data monitoring committee recommended termination of the trial. The decision to terminate the trial was not based on any safety concerns.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Outpatients with DSM-IV major depressive disorder
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Exclusion Criteria
- Women of child bearing potential
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in HAM-D (17) at the week 6 visit
- Secondary Outcome Measures
Name Time Method Change from baseline in MADRS, HAM-A, CGI-S and CGI-I at the week 6 visit.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇷🇺St.-Petersburg, Russian Federation