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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:
ClinicalTrials.gov Identifier:
NCT00143091
First Posted: September 2, 2005
Last Update Posted: March 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients with DSM-IV major depressive disorder

Exclusion Criteria:

  • Women of child bearing potential
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00143091     History of Changes
Other Study ID Numbers: A2211002
First Submitted: August 31, 2005
First Posted: September 2, 2005
Last Update Posted: March 24, 2008
Last Verified: March 2008

Keywords provided by Pfizer:
Major Depressive Disorder, Recurrent

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs