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Memantine Treatment of Compulsive Buying

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon E. Grant, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00830375
First received: January 23, 2009
Last updated: April 9, 2012
Last verified: April 2012
History of Changes
  Purpose

This is an 8-week, open-labe study of memantine in the treatment of compulsive buying.


Condition Intervention Phase
Compulsive Buying
 Drug: Memantine
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Memantine Treatment of Compulsive Buying: An Open-Label Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Yale Brown Obsessive Compulsive Scale Modified for CB (CB-YBOCS) [ Time Frame: from study start to study end (8-weeks) and is Investigator rated ] [ Designated as safety issue: No ]
    The CB-YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity). Scores ranging from 0 to 10 reflect minimal or mild symptoms; scores from 11 to 20 suggest moderate symptoms; severe symptoms are associated with scores from 21 to 30; and scores greater than 30 reflect extreme buying symptoms


Enrollment: 10
Study Start Date: December 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Memantine
10-30mg, memantine
 Drug: Memantine
10-30mg, by mouth, daily
Other Name: Namenda

Detailed Description:

The goal of the proposed study is to evaluate the efficacy of memantine in the treatment of compulsive buying. Sixteen subjects meeting criteria for compulsive buying will receive 8 weeks of open-label memantine. The hypothesis to be tested is that memantine will be effective and well tolerated in patients with compulsive buying. 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:

  1. men and women age 18-65
  2. current CB using the clinician-administered Structured Clinical Interview for Compulsive buying (SCI-CB)
  3. buying behavior within 2 weeks prior to enrollment

Exclusion Criteria:

  1. infrequent buying (i.e. less than one time per week) that does not meet proposed criteria for CB
  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, 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
  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: NCT00830375

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Ambulatory Research Center
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Jon Grant, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
Impulse Control Disorders Clinic - University of Minnesota  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jon E. Grant, Professor of Psychiatry, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00830375     History of Changes
Other Study ID Numbers: 0806M37821
Study First Received: January 23, 2009
Results First Received: March 1, 2012
Last Updated: April 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Buying
Shopping
Impulse Control

Additional relevant MeSH terms:
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 October 18, 2012