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

This study is currently recruiting participants.
Verified November 2012 by New York State Psychiatric Institute
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00956085
First received: August 10, 2009
Last updated: November 1, 2012
Last verified: November 2012

August 10, 2009
November 1, 2012
August 2009
December 2012   (final data collection date for primary outcome measure)
Improvement in severity of symptoms as measured by YBOCS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00956085 on ClinicalTrials.gov Archive Site
HAM-D [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Memantine Augmentation in Treatment-Resistant Adults With Obsessive-Compulsive Disorder
Memantine Augmentation in Treatment-Resistant Adults With Obsessive-Compulsive Disorder

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.

see above

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obsessive-Compulsive Disorder
Drug: Memantine
Memantine titrated in 5mg increments weekly to target dose of 10mg po bid; total study duration is 12 weeks
Other Name: Namenda
Experimental: Memantine
Memantine titrated in 5mg increments weekly to target dose of 10mg po bid; total study duration is 12 weeks
Intervention: Drug: Memantine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2012
December 2012   (final data collection date for primary outcome measure)

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, NMDA receptor medications
Both
18 Years to 65 Years
No
Contact: Carolyn I. Rodriguez, M.D., Ph.D. 212-543-5637
United States
 
NCT00956085
5972
No
New York State Psychiatric Institute
New York State Psychiatric Institute
Not Provided
Principal Investigator: Carolyn I. Rodriguez, M.D., Ph.D. NYSPI
New York State Psychiatric Institute
November 2012

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