Study of Memantine Augmentation in Severe Obsessive-Compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

Official title:

A Chart Review of Memantine Use in the Treatment of Obsessive-Compulsive Disorder at the OCD Institute

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869505
• Other study ID #: 2008-P-000461
• Status: Completed
• Phase: N/A
• First received: March 25, 2009
• Last updated: March 25, 2009
• Start date: March 2008

Study information

• Verified date: March 2009
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Locations

Country	Name	City	State
United States	OCD Institute, McLean Hospital	Belmont	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Mclean Hospital, OCD Institute

Country where clinical trial is conducted

United States,