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Study of Memantine Augmentation in Severe Obsessive-Compulsive Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00869505
First Posted: March 26, 2009
Last Update Posted: March 26, 2009
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.
Collaborators:
OCD Institute
Mclean Hospital
Information provided by:
Massachusetts General Hospital
March 25, 2009
March 26, 2009
March 26, 2009
March 2008
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No Changes Posted
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Study of Memantine Augmentation in Severe Obsessive-Compulsive Disorder
A Chart Review of Memantine Use in the Treatment of Obsessive-Compulsive Disorder at the OCD Institute
Memantine is a glutamate receptor antagonist that has been reported to reduce Obsessive-Compulsive Disorder (OCD) symptoms in case studies of treatment-resistant individuals. The investigators hypothesized that memantine is an effective augmenting agent to standard intensive residential treatment of severe OCD. An intent-to-treat, single-blinded, naturalistic case-control design is employed. The sample includes subjects receiving standard treatment at the McLean/ MGH Intensive Residential Treatment (IRT) program, half of whom also receive memantine augmentation. Admission, monthly and discharge measures of OCD, depression and psychosocial functioning are collected by raters blinded to augmentation status. Matched controls are selected based upon gender, initial OCD severity, psychosocial functioning, and timing of admission. Descriptive and comparative analyses are conducted via SPSS, statistical significance is defined at p<0.05, clinically significant response is defined by a 25% reduction, and 'marked response' is defined by a 50% improvement in Yale-Brown Obsessive Compulsive severity (Y-BOCS) scores, using a last-observation-carried-forward approach. The Clinical Global Improvement (CGI) scale captures global clinical change.
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Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Non-Probability Sample
The study population comprised 44 subjects who received standard treatment at the MGH/ McLean Hospital OCD Institute Intensive Residential Treatment (IRT) program, admitted between May 1999 and December 2007.
Obsessive-Compulsive Disorder
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  • Case Group
    Intensive Residential Treatment with memantine augmentation
  • Control Group
    Intensive Residential Treatment without memantine augmentation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  • Consecutive patients of IRT at the OCD Institute who agreed to augmentation with memantine.
  • Consecutive patients of IRT at the OCD Institute who were not offered augmentation with memantine and who were matched according to OCD severity, gender, and psychosocial functioning.

Exclusion Criteria:

  • Subjects offered memantine augmentation who did not provide voluntary consent.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00869505
2008-P-000461
No
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S. Evelyn Stewart, M.D., Director of Research, OCD Institute, Harvard Medical School, Massachusetts General Hospital, McLean Hospital
Massachusetts General Hospital
  • OCD Institute
  • Mclean Hospital
Principal Investigator: S. Evelyn Stewart, MD Massachusetts General Hospital
Massachusetts General Hospital
March 2009