Memantine in the Treatment of Kleptomania

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

Detailed Description
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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.

Official Title
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Memantine Treatment of Kleptomania: An Open-Label Study

Conditions
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Kleptomania

Intervention / Treatment
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* Drug: Memantine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Memantine<br>Memantine 10-30mg | Drug: Memantine<br>* 10-30mg, daily for 8 weeks<br>* Other names: Namenda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS) | 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. | Week 8 (last visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kleptomania Symptom Assessment Scale (K-SAS) | 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. | Week 8 (last visit) | 
| Clinical Global Impression Severity Scales (CGI) | 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. | Week 8 (last visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compulsive Stealing, Compulsive Shoplifting