Memantine in the Treatment of Kleptomania

NCT ID: NCT00880685

Last Updated: 2021-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-06-30

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.

Conditions

Kleptomania

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Memantine

Memantine 10-30mg

Group Type: EXPERIMENTAL

Memantine

Intervention Type: DRUG

10-30mg, daily for 8 weeks

Interventions

Memantine

10-30mg, daily for 8 weeks

Intervention Type: DRUG

Other Intervention Names

Namenda

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon E Grant, MD, JD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

0901M56882

Identifier Type: -

Identifier Source: org_study_id