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OpenTrials
Completed

NCT Number: NCT00880685

Memantine in the Treatment of Kleptomania

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 kleptomania (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 Structured Clinical Interview for the DSM (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.

Treatment and study plan

Memantine

Drug

10-30mg, daily for 8 weeks

Other names: Namenda

Primary outcomes

  1. Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS)

    Time frame: Week 8 (last visit)

    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 Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (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.

Secondary outcomes

  1. Kleptomania Symptom Assessment Scale (K-SAS)

    Time frame: Week 8 (last visit)

    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.

  2. Clinical Global Impression Severity Scales (CGI)

    Time frame: Week 8 (last visit)

    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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Memantine Treatment of Kleptomania: An Open-Label Study

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 14, 2009
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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