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
|Condition or disease||Intervention/treatment||Phase|
|Pathological Gambling||Drug: Memantine Hydrochloride||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Open-Label Multi-Center Trial of Memantine (Namenda(TM)) Treatment of Pathological Gambling|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585169
|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|
|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|