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Memantine Augmentation in Obsessive-Compulsive Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00264238
First Posted: December 12, 2005
Last Update Posted: May 30, 2017
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.
Information provided by (Responsible Party):
John J Barry, Stanford University
  Purpose
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 Intervention Phase
Obsessive-Compulsive Disorder Drug: Memantine Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by John J Barry, Stanford University:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 15
Study Start Date: January 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: John J Barry, MD Stanford University
  More Information

Publications:
Responsible Party: John J Barry, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00264238     History of Changes
Other Study ID Numbers: SUSPO34313
First Submitted: December 9, 2005
First Posted: December 12, 2005
Results First Submitted: November 7, 2016
Results First Posted: May 30, 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:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
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