Memantine Treatment Study of Pathological Gambling

This study has been completed.
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
Forest Laboratories
Information provided by (Responsible Party):
Marc Potenza, Yale University
ClinicalTrials.gov Identifier:
NCT00585169
First received: December 25, 2007
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) [ Time Frame: Baseline to study end point (10 weeks) ] [ Designated as safety issue: No ]
    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.


Enrollment: 29
Study Start Date: December 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585169

Locations
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 - Clinical and Translational Science Institute
Forest Laboratories
Investigators
Principal Investigator: Marc N. Potenza, M.D, Ph.D. Yale University
Principal Investigator: Jon E Grant, MD, JD, MPH University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
Publications:
Responsible Party: Marc Potenza, Professor of Psychiatry, Child Study, and Neurobiology, Yale University
ClinicalTrials.gov Identifier: NCT00585169     History of Changes
Other Study ID Numbers: 0705002703*, HIC 0705002703
Study First Received: December 25, 2007
Results First Received: January 29, 2013
Last Updated: March 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Pathological Gambling
Compulsive Gambling
Gambling Addiction
Gambling
Treatment
Memantine
Pharmacology

Additional relevant MeSH terms:
Gambling
Impulse Control Disorders
Mental Disorders
Memantine
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014