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

March 19, 2008 updated by: Pfizer

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Former Serbia and Montenegro
      • Belgrade, Former Serbia and Montenegro
        • Pfizer Investigational Site
    • Serbia
      • Belgrade, Serbia, Former Serbia and Montenegro
        • Pfizer Investigational Site
      • Kragujevac, Serbia, Former Serbia and Montenegro
        • Pfizer Investigational Site
      • Novi Sad, Serbia, Former Serbia and Montenegro
        • Pfizer Investigational Site
  • Russian Federation
      • 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, Russian Federation
        • Pfizer Investigational Site
  • United States
    • Washington
      • Bellevue, Washington, United States
        • Pfizer Investigational Site
      • Seattle, Washington, United States
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Outpatients with DSM-IV major depressive disorder

Exclusion Criteria:

  • Women of child bearing potential

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in HAM-D (17) at the week 6 visit

Secondary Outcome Measures

Outcome Measure
Change from baseline in MADRS, HAM-A, CGI-S and CGI-I at the week 6 visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion

December 7, 2022

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

March 24, 2008

Last Update Submitted That Met QC Criteria

March 19, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2211002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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