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

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