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Memantine in the Treatment of Kleptomania
This study is currently recruiting participants.
Verified by University of Minnesota, April 2009
First Received: March 18, 2009   Last Updated: April 10, 2009   History of Changes
Sponsored by: University of Minnesota
Information provided by: University of Minnesota
ClinicalTrials.gov Identifier: NCT00880685
  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 II

Drug Information available for: Memantine Memantine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Memantine Treatment of Kleptomania: An Open-Label Study

Further study details as provided by University of Minnesota:

Primary Outcome Measures:
  • Yale Brown Obsessive Compulsive Scale Modified for KM (KM-YBOCS) [ Time Frame: Baseline and Weeks 2, 4, 6, and 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Kleptomania Symptom Assessment Scale (K-SAS) [ Time Frame: Baseline and Weeks 2, 4, 6, and 8 ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Improvement and Severity scales (CGI) [ Time Frame: Baseline (Severity only) and Weeks 2, 4, 6, and 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Memantine: Experimental
Memantine 10-30mg
Drug: Memantine
10-30mg, daily for 8 weeks

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880685

Contacts
Contact: Brian L Odlaug, BA 612-627-4363 odla0019@umn.edu
Contact: Jon E Grant, MD, JD 612-273-9736 grant045@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Brian L Odlaug, BA     612-627-4363     odla0019@umn.edu    
Contact: Jon E Grant, MD, JD     612-273-9736     grant045@umn.edu    
Principal Investigator: Jon E Grant, MD            
Sub-Investigator: S W Kim, MD            
Sponsors and Collaborators
University of Minnesota
Investigators
Principal Investigator: Jon E Grant, MD, JD University of Minnesota
  More Information

No publications provided

Responsible Party: University of Minnesota ( Jon E Grant, MD, JD )
Study ID Numbers: 0901M56882
Study First Received: March 18, 2009
Last Updated: April 10, 2009
ClinicalTrials.gov Identifier: NCT00880685     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Minnesota:
Compulsive Stealing
Compulsive Shoplifting

Study placed in the following topic categories:
Excitatory Amino Acids
Neurotransmitter Agents
Impulse Control Disorders
Dopamine
Mental Disorders
Memantine
Dopamine Agents

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Antiparkinson Agents
Excitatory Amino Acid Agents
Pharmacologic Actions
Impulse Control Disorders
Mental Disorders
Therapeutic Uses
Memantine
Dopamine Agents
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on May 07, 2009