Memantine in the Treatment of Kleptomania

Phase 2

Completed

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

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

infrequent stealing (i.e. less than one time per week) that does not meet proposed criteria for kleptomania (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 Structured Clinical Interview for the DSM (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.

Arm && Interventions

Group	Intervention	Description
Memantine	Memantine	Memantine 10-30mg

Primary Outcome Measures

Name	Time	Method
Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS)	Week 8 (last visit)	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 Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (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

Name	Time	Method
Kleptomania Symptom Assessment Scale (K-SAS)	Week 8 (last visit)	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)	Week 8 (last visit)	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.