Memantine Treatment Study of Pathological Gambling

NCT ID: NCT00585169

Last Updated: 2013-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2011-12-31

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.

Conditions

Pathological Gambling

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Memantine Hydrochloride

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Namenda

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: collaborator

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Marc Potenza

Professor of Psychiatry, Child Study, and Neurobiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc N. Potenza, M.D, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Jon E Grant, MD, JD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, United States

Countries

United States

References

Grant JE, Chamberlain SR, Odlaug BL, Potenza MN, Kim SW. Memantine shows promise in reducing gambling severity and cognitive inflexibility in pathological gambling: a pilot study. Psychopharmacology (Berl). 2010 Dec;212(4):603-12. doi: 10.1007/s00213-010-1994-5. Epub 2010 Aug 19.

Reference Type: RESULT

PMID: 20721537 (View on PubMed)

Related Links

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

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

http://www.impulsecontroldisorders.org/

University of Minnesota Impulse Control Disorders Clinic

Other Identifiers

HIC 0705002703

Identifier Type: OTHER

Identifier Source: secondary_id

0705002703*

Identifier Type: -

Identifier Source: org_study_id