Memantine Augmentation in Obsessive-Compulsive Disorder

Phase 1

Completed

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Drug: Memantine

• Registration Number: NCT00264238
• Lead Sponsor: Stanford University

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).

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 Timeline

• Study First Submitted: 2005-12-09
• Study First Submitted QC: 2005-12-09
• Study First Posted: 2005-12-12
• Study Start: 2006-01
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2016-11-07
• Results First Submitted QC: 2017-01-17
• Results First Posted: 2017-03-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Memantine open label	Memantine	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.

Primary Outcome Measures

Name	Time	Method
Mean Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) From Baseline to End of Treatment (12 Weeks)	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

Name	Time	Method
Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to End of Treatment (12 Weeks)	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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States