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

NCT ID: NCT00143091

Last Updated: 2008-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-04-30

Brief Summary

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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

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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.

Conditions

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Depressive Disorder, Major

Keywords

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Major Depressive Disorder, Recurrent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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CP-316,311

Intervention Type DRUG

Placebo

Intervention Type DRUG

Sertraline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatients with DSM-IV major depressive disorder

Exclusion Criteria

* Women of child bearing potential
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Bellevue, Washington, United States

Site Status

Pfizer Investigational Site

Seattle, Washington, United States

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Rostov-on-Don, , Russia

Site Status

Pfizer Investigational Site

Saint Petersburg, , Russia

Site Status

Pfizer Investigational Site

Smolensk, , Russia

Site Status

Pfizer Investigational Site

Belgrade, Serbia, Serbia and Montenegro

Site Status

Pfizer Investigational Site

Kragujevac, Serbia, Serbia and Montenegro

Site Status

Pfizer Investigational Site

Novi Sad, Serbia, Serbia and Montenegro

Site Status

Pfizer Investigational Site

Belgrade, , Serbia and Montenegro

Site Status

Countries

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United States Russia Serbia and Montenegro

References

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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.

Reference Type DERIVED
PMID: 18413705 (View on PubMed)

Related Links

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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+

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Other Identifiers

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A2211002

Identifier Type: -

Identifier Source: org_study_id