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Completed

NCT Number: NCT00264238

Memantine Augmentation in 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).

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Memantine

Drug

pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder

Other names: Namenda

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

An Open-Label Trial of Memantine to Augment Response in the Treatment of Obsessive-Compulsive Disorder

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 12, 2005
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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