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NCT00143091 Clinical Trial

Multicentre Trial to Evaluate the Safety and Efficacy of CP-316,311 in Major Depressive Disorder

Depressive Disorder, Major Clinical Trial

Official title:
A Six-Week, Fixed Dose, Double-Blind, Double-Dummy, Placebo and Sertraline Controlled, Multicentre Trial to Evaluate the Safety and Efficacy of CP-316,311 in Outpatients With Major Depressive Disorder

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00143091
Other study ID # A2211002
Secondary ID
Status Terminated
Phase Phase 2
First received August 31, 2005
Last updated March 19, 2008
Start date April 2005
Est. completion date April 2006

Study information
Verified date March 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Terminated
Enrollment 200
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Outpatients with DSM-IV major depressive disorder

Exclusion Criteria:

- Women of child bearing potential

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• CP-316,311

• Placebo

• Sertraline

Locations
Country Name City State
Former Serbia and Montenegro Pfizer Investigational Site Belgrade Serbia
Former Serbia and Montenegro Pfizer Investigational Site Belgrade
Former Serbia and Montenegro Pfizer Investigational Site Kragujevac Serbia
Former Serbia and Montenegro Pfizer Investigational Site Novi Sad Serbia
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Rostov On Don
Russian Federation Pfizer Investigational Site Smolensk
Russian Federation Pfizer Investigational Site St Petersburg
Russian Federation Pfizer Investigational Site St. Petersburg
Russian Federation Pfizer Investigational Site St.-Petersburg
United States Pfizer Investigational Site Bellevue Washington
United States Pfizer Investigational Site Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Former Serbia and Montenegro,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in HAM-D (17) at the week 6 visit
Secondary Change from baseline in MADRS, HAM-A, CGI-S and CGI-I at the week 6 visit.
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