Memantine Treatment Study of Pathological Gambling

Pathological Gambling Clinical Trial

Official title:

A Phase II Open-Label Multi-Center Trial of Memantine (Namenda(TM)) Treatment of Pathological Gambling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00585169
• Other study ID #: 0705002703*
• Secondary ID: HIC 0705002703
• Status: Completed
• Phase: Phase 2
• First received: December 25, 2007
• Last updated: March 5, 2013
• Start date: December 2007
• Est. completion date: December 2011

Study information

• Verified date: March 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gambling
• Pathological Gambling

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center, Fairview	Minneapolis	Minnesota
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Forest Laboratories, University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)	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.	Baseline to study end point (10 weeks)	No

External Links

•   Drug info available from FDA's Drugs@FDA web site
•   Yale University School of Medicine