Official Title: “A Phase II Open-Label Multi-Center Trial of Memantine (Namenda(TM)) Treatment of Pathological Gambling”

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.

Study Type: Interventional

Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2011

Intervention(s) in this Clinical Trial

• Drug: Memantine Hydrochloride
  • 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 4 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks.

Primary Measures

• Improvement in patient overall functioning
  • Time Frame: Upon study completion
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

Marc N. Potenza, M.D, Ph.D. Principal Investigator Yale University  

Overall Contact: Jennifer D. Bellegarde, New Haven, CT (203) 974-7072 jennifer.bellegarde@yale.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00585169

Study ID Number: 0705002703*

ClinicalTrials.gov Identifier: NCT00585169

Health Authority: United States: Food and Drug Administration

Drug info available from FDA's Drugs@FDA web site

Yale University School of Medicine

University of Minnesota Impulse Control Disorders Clinic