Study of Memantine Augmentation in Severe Obsessive-Compulsive Disorder

This study has been completed.
Sponsor:
Collaborators:
OCD Institute
Mclean Hospital
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00869505
First received: March 25, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition
Obsessive-Compulsive Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Chart Review of Memantine Use in the Treatment of Obsessive-Compulsive Disorder at the OCD Institute

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Study Start Date: March 2008
Groups/Cohorts
Case Group
Intensive Residential Treatment with memantine augmentation
Control Group
Intensive Residential Treatment without memantine augmentation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869505

Locations
United States, Massachusetts
OCD Institute, McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Massachusetts General Hospital
OCD Institute
Mclean Hospital
Investigators
Principal Investigator: S. Evelyn Stewart, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: S. Evelyn Stewart, M.D., Director of Research, OCD Institute, Harvard Medical School, Massachusetts General Hospital, McLean Hospital
ClinicalTrials.gov Identifier: NCT00869505     History of Changes
Other Study ID Numbers: 2008-P-000461
Study First Received: March 25, 2009
Last Updated: March 25, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
To evaluate the effectiveness of memantine as an augmenting agent for standard intensive residential treatment of severe obsessive-compulsive disorder (OCD)

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on October 01, 2014