Clinical trial NCT00880685: Memantine in the Treatment of Kleptomania
Official title: Memantine Treatment of Kleptomania: An Open-Label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kleptomania
Keywords: Compulsive Stealing
Compulsive Shoplifting
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-04-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS)
timeFrame: Week 8 (last visit)
Secondary outcomes:
measure: Kleptomania Symptom Assessment Scale (K-SAS)
timeFrame: Week 8 (last visit)
measure: Clinical Global Impression Severity Scales (CGI)
timeFrame: Week 8 (last visit)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jon E Grant, MD, JD
role: PRINCIPAL_INVESTIGATOR
References: