Memantine in the Treatment of Kleptomania
This study has been completed.
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Jon E. Grant, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00880685
First received: March 18, 2009
Last updated: June 27, 2012
Last verified: June 2012
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Purpose
The goal of the proposed study is to evaluate the efficacy and safety of memantine in kleptomania.
| Condition | Intervention | Phase |
|---|---|---|
|
Kleptomania |
Drug: Memantine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Memantine Treatment of Kleptomania: An Open-Label Study |
Resource links provided by NLM:
Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:
Primary Outcome Measures:
- Yale Brown Obsessive Compulsive Scale Modified for KM (KM-YBOCS) [ Time Frame: Baseline and Weeks 2, 4, 6, and 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Kleptomania Symptom Assessment Scale (K-SAS) [ Time Frame: Baseline and Weeks 2, 4, 6, and 8 ] [ Designated as safety issue: No ]
- Clinical Global Impression-Improvement and Severity scales (CGI) [ Time Frame: Baseline (Severity only) and Weeks 2, 4, 6, and 8 ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | March 2009 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Memantine
Memantine 10-30mg
|
Drug: Memantine
10-30mg, daily for 8 weeks
Other Name: Namenda
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- infrequent stealing (i.e. less than one time per week) that does not meet proposed criteria for 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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880685
Locations
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55454 | |
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
| Principal Investigator: | Jon E Grant, MD, JD | University of Minnesota - Clinical and Translational Science Institute |
More Information
No publications provided
| Responsible Party: | Jon E. Grant, Professor of Psychiatry, University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00880685 History of Changes |
| Other Study ID Numbers: | 0901M56882 |
| Study First Received: | March 18, 2009 |
| Last Updated: | June 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
|
Compulsive Stealing Compulsive Shoplifting |
Additional relevant MeSH terms:
|
Impulse Control Disorders Mental Disorders Memantine Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013