Memantine in the Treatment of Kleptomania

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Chicago
ClinicalTrials.gov Identifier:
NCT00880685
First received: March 18, 2009
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

The goal of the proposed study is to evaluate the efficacy and safety of memantine in kleptomania.


Condition Intervention Phase
Kleptomania
Drug: Memantine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Memantine Treatment of Kleptomania: An Open-Label Study

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Yale Brown Obsessive Compulsive Scale Modified for KM (KM-YBOCS) [ Time Frame: Week 8 (last visit) ] [ Designated as safety issue: No ]
    Scores could range from 0-40 with 0 being the least severe and 40 being the most severe. Here the total score was used. The KM-YBOCS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported. The scale was given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.


Secondary Outcome Measures:
  • Kleptomania Symptom Assessment Scale (K-SAS) [ Time Frame: Week 8 (last visit) ] [ Designated as safety issue: No ]
    Scale used to measure severity of kleptomania. Scores could range from 0-36 with 0 being the least severe and 36 being the most severe. Here the total score was used. The K-SAS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported. The scale was given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.

  • Clinical Global Impression Severity Scales (CGI) [ Time Frame: Week 8 (last visit) ] [ Designated as safety issue: No ]
    The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.


Enrollment: 12
Study Start Date: March 2009
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Memantine
Memantine 10-30mg
Drug: Memantine
10-30mg, daily for 8 weeks
Other Name: Namenda

Detailed Description:

The proposed study will consist of 8 weeks of treatment with memantine in 10 subjects with kleptomania. The hypothesis to be tested is that memantine will be effective in reducing the urges to steal in patients with kleptomania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

  Eligibility

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

Inclusion Criteria:

  1. men and women age 18-65
  2. current KM using the clinician-administered Structured Clinical Interview for Kleptomania (SCI-K)
  3. stealing behavior within 2 weeks prior to enrollment.

Exclusion Criteria:

  1. infrequent stealing (i.e. less than one time per week) that does not meet proposed criteria for KM
  2. unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screen
  3. history of seizures
  4. myocardial infarction within 6 months
  5. current pregnancy or lactation, or inadequate contraception in women of childbearing potential
  6. a need for medication other than memantine with possible psychotropic effects or unfavorable interactions
  7. clinically significant suicidality
  8. current Axis I disorder determined by the SCID and SCID-compatible modules for impulse control disorders (Grant et al., 2005), except for nicotine dependence
  9. lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any psychotic disorder determined by SCID
  10. current or recent (past 3 months) DSM-IV substance abuse or dependence
  11. positive urine drug screen at screening
  12. initiation of psychotherapy or behavior therapy within 3 months prior to study baseline
  13. previous treatment with memantine; and 14) treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline.
  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: NCT00880685

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Jon E Grant, MD, JD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Jon Grant, Professor of Psychiatry, University of Chicago
ClinicalTrials.gov Identifier: NCT00880685     History of Changes
Other Study ID Numbers: 0901M56882
Study First Received: March 18, 2009
Results First Received: August 19, 2013
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
Compulsive Stealing
Compulsive Shoplifting

Additional relevant MeSH terms:
Impulse Control Disorders
Mental 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 21, 2014