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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
December 9, 2005
December 12, 2005
November 7, 2016
May 30, 2017
May 30, 2017
January 2006
June 2008   (Final data collection date for primary outcome measure)
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
Y-BOCS score at final study visit
Complete list of historical versions of study NCT00264238 on ClinicalTrials.gov Archive Site
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.
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Memantine Augmentation in Obsessive-Compulsive Disorder
An Open-Label Trial of Memantine to Augment Response in the Treatment of Obsessive-Compulsive Disorder
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).
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.
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Obsessive-Compulsive Disorder
Drug: Memantine
pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder
Other Name: Namenda
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.
Intervention: Drug: Memantine
Aboujaoude E, Barry JJ, Gamel N. Memantine augmentation in treatment-resistant obsessive-compulsive disorder: an open-label trial. J Clin Psychopharmacol. 2009 Feb;29(1):51-5. doi: 10.1097/JCP.0b013e318192e9a4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
June 2008
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00264238
SUSPO34313
No
Not Provided
Plan to Share IPD: No
John J Barry, Stanford University
Stanford University
Not Provided
Principal Investigator: John J Barry, MD Stanford University
Stanford University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP