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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Pfizer Investigational Site
Bellevue, Washington, United States
Pfizer Investigational Site
Seattle, Washington, United States
Pfizer Investigational Site
Moscow, Russia
Pfizer Investigational Site
Change from baseline in HAM-D (17) at the week 6 visit
Change from baseline in MADRS, HAM-A, CGI-S and CGI-I at the week 6 visit.
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Rostov-on-Don, Russia
Pfizer Investigational Site
Saint Petersburg, Russia
Pfizer Investigational Site
Smolensk, Russia
Pfizer Investigational Site
Belgrade, Serbia, Serbia and Montenegro
Pfizer Investigational Site
Kragujevac, Serbia, Serbia and Montenegro
Pfizer Investigational Site
Novi Sad, Serbia, Serbia and Montenegro
Pfizer Investigational Site
Belgrade, Serbia and Montenegro