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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00163059
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : September 22, 2006
Sponsor:
Information provided by:

Study Description
Brief Summary:
To determine if the NMDA antagonist, CP-101,606, is effective for depression

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: NMDA Antagonist, CP-101,606 (traxoprodil) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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
Study Start Date : May 2004
Estimated Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. MADRS

Secondary Outcome Measures :
  1. HAM-D

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163059


Locations
United States, Kansas
Pfizer Investigational Site
Wichita, Kansas, United States, 67214-2878
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00163059     History of Changes
Other Study ID Numbers: A1611006
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: September 22, 2006
Last Verified: September 2006

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs