Back to resultsThe Antidepressant Effects Of The NMDA Antagonist, CP-101,606, In Patients With MDD
Primary Purpose
Depressive Disorder, Major
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NMDA Antagonist, CP-101,606 (traxoprodil)
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major
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).
Sites / Locations
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
MADRS
Secondary Outcome Measures
HAM-D
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00163059
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
To determine if the NMDA antagonist, CP-101,606, is effective for depression
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
NMDA Antagonist, CP-101,606 (traxoprodil)
Primary Outcome Measure Information:
Title
MADRS
Secondary Outcome Measure Information:
Title
HAM-D
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-2878
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1611006&StudyName=The+Antidepressant+Effects+Of+The+NMDA+Antagonist%2C+CP%2D101%2C606%2C+In+Patients+With+MDD
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
The Antidepressant Effects Of The NMDA Antagonist, CP-101,606, In Patients With MDD
We'll reach out to this number within 24 hrs