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

Primary Purpose

Depressive Disorder, Major

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CP-316,311
Placebo
Sertraline
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Major Depressive Disorder, Recurrent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Outpatients with DSM-IV major depressive disorder Exclusion Criteria: Women of child bearing potential

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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.

Full Information

First Posted
August 31, 2005
Last Updated
March 19, 2008
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00143091
Brief Title
Multicentre Trial to Evaluate the Safety and Efficacy of CP-316,311 in Major Depressive Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Terminated
Why Stopped
See Detailed Description for termination reason.
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Major Depressive Disorder, Recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CP-316,311
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Sertraline
Primary Outcome Measure Information:
Title
Change from baseline in HAM-D (17) at the week 6 visit
Secondary Outcome Measure Information:
Title
Change from baseline in MADRS, HAM-A, CGI-S and CGI-I at the week 6 visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients with DSM-IV major depressive disorder Exclusion Criteria: Women of child bearing potential
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Pfizer Investigational Site
City
Belgrade
State/Province
Serbia
Country
Former Serbia and Montenegro
Facility Name
Pfizer Investigational Site
City
Kragujevac
State/Province
Serbia
Country
Former Serbia and Montenegro
Facility Name
Pfizer Investigational Site
City
Novi Sad
State/Province
Serbia
Country
Former Serbia and Montenegro
Facility Name
Pfizer Investigational Site
City
Belgrade
Country
Former Serbia and Montenegro
Facility Name
Pfizer Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Rostov On Don
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Smolensk
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St Petersburg
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St.-Petersburg
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
18413705
Citation
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. doi: 10.1176/appi.ajp.2008.07071199. Epub 2008 Apr 15.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2211002&StudyName=Multicentre+Trial+to+Evaluate+the+Safety+and+Efficacy+of+CP%2D316%2C311+in+Major+Depressive+Disorder+
Description
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Multicentre Trial to Evaluate the Safety and Efficacy of CP-316,311 in Major Depressive Disorder

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