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

This study has been terminated.
(See Detailed Description for termination reason.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143091
First received: August 31, 2005
Last updated: March 19, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Depressive Disorder, Major
Drug: CP-316,311
Drug: Placebo
Drug: Sertraline
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in HAM-D (17) at the week 6 visit

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

Estimated Enrollment: 200
Study Start Date: April 2005
Study Completion Date: April 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients with DSM-IV major depressive disorder

Exclusion Criteria:

  • Women of child bearing potential
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143091

Locations
United States, Washington
Pfizer Investigational Site
Bellevue, Washington, United States
Pfizer Investigational Site
Seattle, Washington, United States
Former Serbia and Montenegro
Pfizer Investigational Site
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
Belgrade, Former Serbia and Montenegro
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, Russian Federation
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00143091     History of Changes
Other Study ID Numbers: A2211002
Study First Received: August 31, 2005
Last Updated: March 19, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Major Depressive Disorder, Recurrent

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014