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

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 II

MedlinePlus related topics:

Depression

ChemIDplus related topics:

Sertraline hydrochloride Sertraline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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

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

Russian Federation
	Pfizer Investigational Site
	Moscow, 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
	Rostov On Don, Russian Federation
	Pfizer Investigational Site
	Smolensk, Russian Federation

Serbia and Montenegro
	Pfizer Investigational Site
	Belgrade, Serbia and Montenegro

Serbia and Montenegro, Serbia
	Pfizer Investigational Site
	Belgrade, Serbia, Serbia and Montenegro
	Pfizer Investigational Site
	Novi Sad, Serbia, Serbia and Montenegro
	Pfizer Investigational Site
	Kragujevac, Serbia, Serbia and Montenegro

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Binneman B, Feltner D, Kolluri S, Shi Y, Qiu R, Stiger T. A 6-week randomized, placebo-controlled trial of CP-316,311 (a selective CRH1 antagonist) in the treatment of major depression. Am J Psychiatry. 2008 May;165(5):617-20. Epub 2008 Apr 15.

Study ID Numbers:	A2211002
First Received:	August 31, 2005
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00143091
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Major Depressive Disorder, Recurrent

Study placed in the following topic categories:

Depression

Mental Disorders

Mood Disorders

Sertraline

Depressive Disorder, Major

Depressive Disorder

Serotonin

Recurrence

Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Disease

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Serotonin Uptake Inhibitors

Pharmacologic Actions

Pathologic Processes

Serotonin Agents

Therapeutic Uses

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00143091