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Memantine Treatment Study of Pathological Gambling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00585169
Recruitment Status : Completed
First Posted : January 3, 2008
Results First Posted : April 8, 2013
Last Update Posted : April 8, 2013
University of Minnesota
Forest Laboratories
Information provided by (Responsible Party):
Marc Potenza, Yale University

Brief Summary:
The goal of the proposed study is to evaluate the efficacy and safety of the drug memantine in individuals with pathological gambling (PG). Thirty subjects with DSM-IV PG will receive 10 weeks of open-label treatment with memantine. The hypothesis to be tested is that memantine will be effective and well tolerated in patients with PG. We hypothesize that memantine will reduce the severity of gambling symptoms and improve patients' overall functioning. This study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Condition or disease Intervention/treatment Phase
Pathological Gambling Drug: Memantine Hydrochloride Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open-Label Multi-Center Trial of Memantine (Namenda(TM)) Treatment of Pathological Gambling
Study Start Date : December 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: memantine
10 to 30 mg/day memantine. The study consisted of 10 weeks of open-label memantine. All eligible study subjects were started at 10 mg/day for 2 weeks. The dose was increased to 20 mg/day after 2 weeks and then to 30 mg/day after 4 weeks unless remission of PG symptoms was attained at a lower dose.
Drug: Memantine Hydrochloride
10 mg/day for two weeks, dose increase to 20 mg at week 3, 30 mg at week 4 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks.
Other Name: Namenda

Primary Outcome Measures :
  1. Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) [ Time Frame: Baseline to study end point (10 weeks) ]
    The PGYBOCS is a reliable & valid, 10-item, clinician administered scale that rates gambling symptoms within the last 7 days. The first 5 questions assess urges and thoughts associated with pathological gambling, and the last 5 questions assess the behavioral component of the disorder. Scores of 0 through 4 are assigned each item according to the severity of the response (0 = least severe response or none, 4 = most severe response or extreme)with a score ranging from 0-40. Each set of questions (1-5 and 6-10) can be totaled separately for the component score (urges/thoughts and behavioral) as well as together for a total score. A score of 0 indicates no problems while increasing scores indicate increasing severity of problems with gambling. PG-YBOCS is used to measure changes across time. A decreasing score indicates a possible positive response to the intervention. Total score at baseline was compared with the study end to determine if the intervention was efficacious.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of Pathological Gambling using the clinician-administered Structured Clinical Interview for Pathological Gambling (SCI-PG) (Grant et al., 2004);
  • Gambling behavior within 2 weeks prior to enrollment;
  • For women, negative results on a urine pregnancy test and stable use of a medically accepted form of contraception.

Exclusion Criteria:

  • Infrequent gambling (i.e. less than one time per week) that does not meet DSM-IV criteria for PG;
  • Unstable medical illness or clinically significant abnormalities on laboratory tests, EKG, 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00585169

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United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Minnesota
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
Yale University
University of Minnesota
Forest Laboratories
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Principal Investigator: Marc N. Potenza, M.D, Ph.D. Yale University
Principal Investigator: Jon E Grant, MD, JD, MPH University of Minnesota

Additional Information:
Publications of Results:
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Responsible Party: Marc Potenza, Professor of Psychiatry, Child Study, and Neurobiology, Yale University Identifier: NCT00585169    
Other Study ID Numbers: 0705002703*
HIC 0705002703 ( Other Identifier: Yale University )
First Posted: January 3, 2008    Key Record Dates
Results First Posted: April 8, 2013
Last Update Posted: April 8, 2013
Last Verified: March 2013
Keywords provided by Marc Potenza, Yale University:
Pathological Gambling
Compulsive Gambling
Gambling Addiction
Additional relevant MeSH terms:
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Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents