Memantine in the Treatment of Kleptomania

Memantine Treatment of Kleptomania: An Open-Label Study

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

Study Overview

• Status: Completed
• Conditions: Kleptomania
• Intervention / Treatment: Drug: Memantine

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Memantine; Memantine 10-30mg	Drug: Memantine; 10-30mg, daily for 8 weeks; Other Names: Namenda

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: March 18, 2009
• First Submitted That Met QC Criteria: April 10, 2009
• First Posted (Estimate): April 14, 2009

Study Record Updates

• Last Update Posted (Actual): May 24, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Compulsive Shoplifting; Compulsive Stealing
• Additional Relevant MeSH Terms: Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Memantine
• Other Study ID Numbers: 0901M56882