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

Pfizer logo

Pfizer

Status and phase

Terminated
Phase 2

Conditions

Depressive Disorder, Major

Treatments

Drug: Sertraline
Drug: CP-316,311
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00143091
A2211002

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Outpatients with DSM-IV major depressive disorder

Exclusion criteria

  • Women of child bearing potential

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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