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NCT00163059 Clinical Trial

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

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00163059
Other study ID # A1611006
Secondary ID
Status Completed
Phase Phase 2
First received September 9, 2005
Last updated September 21, 2006
Start date May 2004
Est. completion date December 2005

Study information
Verified date September 2006
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Pfizer Investigational Site Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary MADRS
Secondary HAM-D
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