Memantine in the Treatment of Kleptomania

NCT00880685 | Completed Phase 2 Results DMC

• 1 other identifier: 0901M56882
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kleptomania

Keywords

Compulsive Stealing; Compulsive Shoplifting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Kleptomania Symptom Assessment Scale (K-SAS)

  Week 8 (last visit)

• Clinical Global Impression Severity Scales (CGI)

  Week 8 (last visit)

Study Arms (1)

Memantine

EXPERIMENTAL

Memantine 10-30mg

Drug: Memantine

Interventions

Memantine DRUG

10-30mg, daily for 8 weeks

Also known as: Namenda

Memantine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Disruptive, Impulse Control, and Conduct Disorders

Interventions

Memantine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Jon Grant
• Organization: University of Chicago

jongrant@uchicago.edu

773-834-1326

Study Officials

• Jon E Grant, MD, JD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2009
• First Posted: April 14, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 24, 2021
• Results First Posted: March 5, 2014

Record last verified: 2021-04

Locations

US (1)