Study of Memantine Augmentation in Severe Obsessive-Compulsive Disorder

NCT ID: NCT00869505

Last Updated: 2009-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obsessive-Compulsive Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Case Group

Intensive Residential Treatment with memantine augmentation

No interventions assigned to this group

Control Group

Intensive Residential Treatment without memantine augmentation

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OCD Institute

UNKNOWN

Sponsor Role collaborator

Mclean Hospital

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Harvard Medical School, Massachusetts General Hospital, McLean Hospital

Principal Investigators

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S. Evelyn Stewart, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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OCD Institute, McLean Hospital

Belmont, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2008-P-000461

Identifier Type: -

Identifier Source: org_study_id

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