The Antidepressant Effects Of The NMDA Antagonist, CP-101,606, In Patients With MDD - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 9, 2005

Last Updated Date

September 21, 2006

Start Date ^†

May 2004

Current Primary Outcome Measures ^†

MADRS

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00163059 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

HAM-D

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

The Antidepressant Effects Of The NMDA Antagonist, CP-101,606, In Patients With MDD

Official Title ^†

A Randomized, Double-Blinded, Placebo-Controlled Trial To Assess The Antidepressant Effects Of The NMDA Antagonist, CP-101,606, In Patients With Treatment Refractory Major Depressive Disorder

Brief Summary

To determine if the NMDA antagonist, CP-101,606, is effective for depression

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Depressive Disorder, Major

Intervention ^†

Drug: NMDA Antagonist, CP-101,606 (traxoprodil)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

December 2005

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Primary DSM-IV diagnosis of MDD

Exclusion Criteria:

Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00163059

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

September 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.