Memantine in the Treatment of Kleptomania
This study has been completed.
Information provided by (Responsible Party):
Jon Grant, University of Chicago
First received: March 18, 2009
Last updated: January 17, 2014
Last verified: January 2014
The goal of the proposed study is to evaluate the efficacy and safety of memantine in kleptomania.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Memantine Treatment of Kleptomania: An Open-Label Study
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2012 (Final data collection date for primary outcome measure)
10-30mg, daily for 8 weeks
Other Name: Namenda
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.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- men and women age 18-65
- current KM using the clinician-administered Structured Clinical Interview for Kleptomania (SCI-K)
- stealing behavior within 2 weeks prior to enrollment.
- infrequent stealing (i.e. less than one time per week) that does not meet proposed criteria for KM
- unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screen
- history of seizures
- myocardial infarction within 6 months
- current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- a need for medication other than memantine with possible psychotropic effects or unfavorable interactions
- clinically significant suicidality
- current Axis I disorder determined by the SCID and SCID-compatible modules for impulse control disorders (Grant et al., 2005), except for nicotine dependence
- lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any psychotic disorder determined by SCID
- current or recent (past 3 months) DSM-IV substance abuse or dependence
- positive urine drug screen at screening
- initiation of psychotherapy or behavior therapy within 3 months prior to study baseline
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00880685
|University of Minnesota
|Minneapolis, Minnesota, United States, 55454 |
University of Chicago
||Jon E Grant, MD, JD
||University of Minnesota - Clinical and Translational Science Institute
No publications provided
||Jon Grant, Professor of Psychiatry, University of Chicago
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 18, 2009
|Results First Received:
||August 19, 2013
||January 17, 2014
||United States: Food and Drug Administration
Keywords provided by University of Chicago:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Impulse Control Disorders
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents