Memantine Augmentation in Treatment-Resistant Adults With Obsessive-Compulsive Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00956085
First received: August 10, 2009
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3% of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Recent evidence suggest that a different neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from OCD. In this study the investigators are recruiting patients to receive the drug memantine, which is thought to modulate the neurotransmitter glutamate, added to whatever other OCD medications they are taking in a 12-week open label study.


Condition Intervention Phase
Obsessive-Compulsive Disorder
Drug: Memantine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Memantine Augmentation in Treatment-Resistant Adults With Obsessive-Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The Yale-Brown Obsessive Compulsive Scale is the gold standard measure for severity of Obsessive Compulsive symptoms. It will be used in this study to measure changes in symptom severity.


Secondary Outcome Measures:
  • Hamilton Depression Rating Scale (HAM-D) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The Hamilton Depression Rating Scale is a measure of depressive symptoms. It will be used in this study to measure changes in depressive symptoms.


Estimated Enrollment: 20
Study Start Date: August 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Memantine
Memantine titrated in 5mg increments weekly to target dose of 10mg po bid; total study duration is 12 weeks
Drug: Memantine
Memantine titrated in 5mg increments weekly to target dose of 10mg po bid; total study duration is 12 weeks
Other Name: Namenda

Detailed Description:

see above

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-65 years old
  2. Primary Diagnosis of OCD
  3. Physically healthy and females must be using effective contraception
  4. At lease moderate OCD symptoms (Yale-Brown Obsessive-Compulsive Scale [YBOCS]score greater or equal to 16 prior to entering trial)
  5. Able to provide consent
  6. May be on or off selective reuptake inhibitor (SRI) medications

    1. Patients on an SRI medication will be included if the dose is stable and adequate (or if they don't want to increase their dose [e.g. side effects] and have a history of prior SRI or CBT treatment meeting criteria for adequate trial)
    2. Patients not on an SRI medication will be included if they they have failed at least 1 prior trial of standard OCD treatment (e.g. SRIs or CBT)

Exclusion Criteria:

  1. Ongoing treatment with memantine
  2. Patients planning to start CBT during the study period or those who have started CBT within 8 weeks prior to study enrollment
  3. Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder.
  4. Current major depressive disorder (patients must be free of the disorder for three months prior to enrollment). Patients will be excluded if they are moderately to severely depressed, but if they are mildly to moderately depressed they will be included (Hamilton Depression Rating Scale must be <18).
  5. Judged clinically to be at risk of suicide (suicidal ideation, severe depression, or other factors).
  6. Current eating disorder
  7. Females who are pregnant or nursing
  8. Severe renal insufficiency, severe hepatic impairment, or seizure disorder.
  9. Documented history of hypersensitivity or intolerance to memantine.
  10. Concomitant use of trimethoprim, N-methyl-D-aspartate receptor medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956085

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Carolyn I. Rodriguez, M.D., Ph.D. NYSPI
  More Information

Additional Information:
No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00956085     History of Changes
Other Study ID Numbers: 6924R/5972
Study First Received: August 10, 2009
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
OCD

Additional relevant MeSH terms:
Compulsive Personality Disorder
Disease
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Pathologic Processes
Personality Disorders
Memantine
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014