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Memantine in the Treatment of Kleptomania

Primary Purpose

Kleptomania

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Memantine
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kleptomania focused on measuring Compulsive Stealing, Compulsive Shoplifting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 kleptomania (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 Structured Clinical Interview for the DSM (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.

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Memantine

Arm Description

Memantine 10-30mg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 18, 2009
Last Updated
April 27, 2021
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00880685
Brief Title
Memantine in the Treatment of Kleptomania
Official Title
Memantine Treatment of Kleptomania: An Open-Label Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kleptomania
Keywords
Compulsive Stealing, Compulsive Shoplifting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memantine
Arm Type
Experimental
Arm Description
Memantine 10-30mg
Intervention Type
Drug
Intervention Name(s)
Memantine
Other Intervention Name(s)
Namenda
Intervention Description
10-30mg, daily for 8 weeks
Primary Outcome Measure Information:
Title
Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS)
Description
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.
Time Frame
Week 8 (last visit)
Secondary Outcome Measure Information:
Title
Kleptomania Symptom Assessment Scale (K-SAS)
Description
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.
Time Frame
Week 8 (last visit)
Title
Clinical Global Impression Severity Scales (CGI)
Description
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.
Time Frame
Week 8 (last visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon E Grant, MD, JD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States

12. IPD Sharing Statement

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Memantine in the Treatment of Kleptomania

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