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Memantine Augmentation in Treatment-Resistant Adults With Obsessive-Compulsive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00956085
First received: August 10, 2009
Last updated: June 20, 2017
Last verified: June 2017
Results First Received: November 29, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Obsessive-Compulsive Disorder
Intervention: Drug: Memantine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Memantine Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre– to post–6 weeks of memantine).

Participant Flow:   Overall Study
    Memantine
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Memantine Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre– to post–6 weeks of memantine).

Baseline Measures
   Memantine 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Years]
Mean (Standard Deviation)
 34  (9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  33.3% 
Male      8  66.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2  16.7% 
Not Hispanic or Latino      10  83.3% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   8.3% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      5  41.7% 
White      6  50.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures

1.  Primary:   Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.   [ Time Frame: Baseline and 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Carolyn Rodriguez, MD, PhD, Assistant Professor
Organization: Stanford University
phone: 6507236158
e-mail: cr2163@stanford.edu


Publications of Results:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00956085     History of Changes
Other Study ID Numbers: 6924R/5972
Study First Received: August 10, 2009
Results First Received: November 29, 2016
Last Updated: June 20, 2017