Memantine in the Treatment of Kleptomania
Information source: University of Chicago
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kleptomania
Intervention: Memantine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Chicago Official(s) and/or principal investigator(s):
Jon E Grant, MD, JD, Principal Investigator, Affiliation: University of Minnesota - Clinical and Translational Science Institute
Summary
The goal of the proposed study is to evaluate the efficacy and safety of memantine in
kleptomania.
Clinical Details
Official title: Memantine Treatment of Kleptomania: An Open-Label Study
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Yale Brown Obsessive Compulsive Scale Modified for KM (KM-YBOCS)
Secondary outcome: Kleptomania Symptom Assessment Scale (K-SAS)Clinical Global Impression Severity Scales (CGI)
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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 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 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.
Locations and Contacts
University of Minnesota, Minneapolis, Minnesota 55454, United States
Additional Information
Starting date: March 2009
Last updated: January 17, 2014
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