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Memantine Augmentation in Obsessive-Compulsive Disorder

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.
 
ClinicalTrials.gov Identifier: NCT00264238
Recruitment Status : Completed
First Posted : December 12, 2005
Results First Posted : March 7, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
John J Barry, Stanford University

Study Description
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Brief Summary:
The purpose of this study is to determine whether memantine is safe and effective when used as an augmentation to standard treatment for Obsessive-Compulsive Disorder (OCD).

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Drug: Memantine Phase 1 Phase 2

Detailed Description:
The purpose of this study is to determine whether memantine (Namenda), in doses up to 20 mg/day, will be effective in treating the OCD of adult patients who have not responded to their OCD medication. Memantine is not FDA approved for OCD, but is approved for the treatment of Alzheimer's Disease. Memantine appears to work by regulating the activity of glutamate, one of the brain's specialized messenger chemicals, which may play a role in OCD. All patients in the study will receive memantine; no one will receive placebo.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Trial of Memantine to Augment Response in the Treatment of Obsessive-Compulsive Disorder
Study Start Date : January 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Memantine open label
All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.
 Drug: Memantine
pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder
Other Name: Namenda


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) From Baseline to End of Treatment (12 Weeks) [ Time Frame: Baseline and 12 weeks ]
    The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder. In general, the items depend on the patient's report; however, the final rating is based on the clinical judgement of the interviewer. The Y-BOCS is designed to rate symptom severity, not to establish a diagnosis.The scale consists of 10 items summed to determine the level of symptom severity. The total score ranges from 0 to 40 with higher scores indicating greater symptom severity


Secondary Outcome Measures :
  1. Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to End of Treatment (12 Weeks) [ Time Frame: Baseline and 12 weeks ]
    The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on a scale of 0 (no symptoms) to 6 (extreme symptoms) and items are summed. The overall score ranges from 0 to 60. Higher MADRS score indicates more severe depression.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • at least 18 years of age
  • suffering from OCD
  • Y-BOCS score of 18 or greater
  • taking a therapeutic dose of an anti-OCD medication specified in the protocol

Exclusion Criteria:

  • diagnosed with a mental disorder other than OCD
  • taking tiagabine or pregabalin
  • having had a previous trial of memantine
  • receiving therapy for OCD
  • substance abuse in the last 6 months
  • personality disorders sufficiently severe to interfere with study participation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264238


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: John J Barry, MD Stanford University
More Information
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Publications of Results:

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Responsible Party: John J Barry, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00264238    
Other Study ID Numbers: SUSPO34313
First Posted: December 12, 2005    Key Record Dates
Results First Posted: March 7, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders
Memantine
Antiparkinson Agents
 Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents