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

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NCT00143091

Last updated on August 9, 2018
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Study Location
Pfizer Investigational Site
Bellevue, Washington, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Outpatients with DSM-IV major depressive disorder

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Women of child bearing potential

NCT00143091
Pfizer
Terminated
Multicentre Trial to Evaluate the Safety and Efficacy of CP-316,311 in Major Depressive Disorder

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Multicentre Trial to Evaluate the Safety and Efficacy of CP-316,311 in Major Depressive Disorder
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Depressive Disorder, Major
  • Drug: CP-316,311
  • Drug: Placebo
  • Drug: Sertraline
Not Provided
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
April 2006
Not Provided

Inclusion Criteria:

  • Outpatients with DSM-IV major depressive disorder

Exclusion Criteria:

  • Women of child bearing potential
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Former Serbia and Montenegro,   Russian Federation,   United States
 
 
NCT00143091
A2211002
Yes
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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1-800-718-1021

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[email protected]



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