Memantine in the Treatment of Kleptomania

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Chicago
ClinicalTrials.gov Identifier:
NCT00880685
First received: March 18, 2009
Last updated: January 17, 2014
Last verified: January 2014

March 18, 2009
January 17, 2014
March 2009
May 2012   (final data collection date for primary outcome measure)
Yale Brown Obsessive Compulsive Scale Modified for KM (KM-YBOCS) [ Time Frame: Week 8 (last visit) ] [ Designated as safety issue: No ]
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 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.
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 ]
Complete list of historical versions of study NCT00880685 on ClinicalTrials.gov Archive Site
  • Kleptomania Symptom Assessment Scale (K-SAS) [ Time Frame: Week 8 (last visit) ] [ Designated as safety issue: No ]
    Scale used to measure severity of kleptomania. Scores could range from 0-36 with 0 being the least severe and 36 being the most severe. Here the total score was used. The K-SAS 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.
  • Clinical Global Impression Severity Scales (CGI) [ Time Frame: Week 8 (last visit) ] [ Designated as safety issue: No ]
    The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.
  • 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 ]
Not Provided
Not Provided
 
Memantine in the Treatment of Kleptomania
Memantine Treatment of Kleptomania: An Open-Label Study

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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kleptomania
Drug: Memantine
10-30mg, daily for 8 weeks
Other Name: Namenda
Experimental: Memantine
Memantine 10-30mg
Intervention: Drug: Memantine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00880685
0901M56882
Yes
Jon Grant, University of Chicago
University of Chicago
Not Provided
Principal Investigator: Jon E Grant, MD, JD University of Minnesota - Clinical and Translational Science Institute
University of Chicago
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP