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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:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 13, 2005
Last Update Posted Date September 22, 2006
Study Start Date  ICMJE May 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2006)
MADRS
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
Depression Rating Scales
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2006)
HAM-D
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
Cognitive Rating Scales
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Antidepressant Effects Of The NMDA Antagonist, CP-101,606, In Patients With MDD
Official Title  ICMJE 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE Drug: NMDA Antagonist, CP-101,606 (traxoprodil)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 9, 2005)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00163059
Other Study ID Numbers  ICMJE A1611006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP