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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00143091

Enrollment

200

Registered

2005-09-02

Start date

2005-04-30

Completion date

2006-04-30

Last updated

2008-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

Keywords

Major Depressive Disorder, Recurrent

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.

Detailed 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.

Interventions

DRUGCP-316,311

DRUGPlacebo

DRUGSertraline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Outpatients with DSM-IV major depressive disorder

Exclusion criteria

* Women of child bearing potential

Design outcomes

Primary

Measure	Time frame
Change from baseline in HAM-D (17) at the week 6 visit	—

Secondary

Measure	Time frame
Change from baseline in MADRS, HAM-A, CGI-S and CGI-I at the week 6 visit.	—

Countries

Russia, Serbia and Montenegro, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026