Memantine Treatment Study of Pathological Gambling
This study has been completed.
Sponsor:
Yale University
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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
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 Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013