NCT00143091

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_2

Geographic Reach
3 countries

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

March 24, 2008

Status Verified

March 1, 2008

First QC Date

August 31, 2005

Last Update Submit

March 19, 2008

Conditions

Depressive Disorder, Major

Keywords

Major Depressive Disorder, Recurrent

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HAM-D (17) at the week 6 visit

Secondary Outcomes (1)

  • Change from baseline in MADRS, HAM-A, CGI-S and CGI-I at the week 6 visit.

Interventions

CP-316,311DRUG
PlaceboDRUG
SertralineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients with DSM-IV major depressive disorder

You may not qualify if:

  • Women of child bearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Pfizer Investigational Site

Bellevue, Washington, United States

Location

Pfizer Investigational Site

Seattle, Washington, United States

Location

Pfizer Investigational Site

Moscow, Russia

Location

Pfizer Investigational Site

Rostov-on-Don, Russia

Location

Pfizer Investigational Site

Saint Petersburg, Russia

Location

Pfizer Investigational Site

Smolensk, Russia

Location

Pfizer Investigational Site

Belgrade, Serbia, Serbia and Montenegro

Location

Pfizer Investigational Site

Kragujevac, Serbia, Serbia and Montenegro

Location

Pfizer Investigational Site

Novi Sad, Serbia, Serbia and Montenegro

Location

Pfizer Investigational Site

Belgrade, Serbia and Montenegro

Location

Related Publications (1)

  • 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.

    PMID: 18413705DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorRecurrence

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

April 1, 2005

Study Completion

April 1, 2006

Last Updated

March 24, 2008

Record last verified: 2008-03

Locations

SE(4)RU(4)US(2)