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Memantine Treatment Study of Pathological Gambling

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ClinicalTrials.gov Identifier: NCT00585169
Recruitment Status : Completed
First Posted : January 3, 2008
Results First Posted : April 8, 2013
Last Update Posted : April 8, 2013
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
Forest Laboratories
Information provided by (Responsible Party):
Marc Potenza, Yale University

December 25, 2007
January 3, 2008
January 29, 2013
April 8, 2013
April 8, 2013
December 2007
December 2011   (Final data collection date for primary outcome measure)
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.
Improvement in patient overall functioning [ Time Frame: Upon study completion ]
Complete list of historical versions of study NCT00585169 on ClinicalTrials.gov Archive Site
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Memantine Treatment Study of Pathological Gambling
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pathological Gambling
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
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.
Intervention: Drug: Memantine Hydrochloride
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
30
December 2011
December 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00585169
0705002703*
HIC 0705002703 ( Other Identifier: Yale University )
No
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Marc Potenza, Yale University
Yale University
  • University of Minnesota - Clinical and Translational Science Institute
  • Forest Laboratories
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
Yale University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP