A Phase 2 interventional study of Memantine Hydrochloride in Pathological Gambling, sponsored by Yale University. Completed at 2 sites in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-04-08.
Sponsored by Yale University · Phase 2, Interventional, and Treatment
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.
147 studies on the registry are indexed under Gambling; 36 are open to participants now.
This study's enrollment of 29 is below the median of 63 across 120 interventional studies indexed under Gambling.
Browse Gambling studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
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Exclusion Criteria:
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.
Also known as: Namenda
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.
Time frame: Baseline to study end point (10 weeks)
Men and women with a primary diagnosis of Pathological Gambling (PG) were recruited between April 2008 through February 2010
| Milestone | Memantine |
|---|---|
| Started | 29 |
| Completed | 28 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| units on a scale | Memantine |
|---|---|
| Baseline | 21.8 ± 4.3 |
| 10 weeks | 8.9 ± 7.2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Memantine 10mg | — | 0/29 (0%) | 5/29 (17.2%) |
| Memantine 20mg | — | 0/24 (0%) | 6/24 (25%) |
| Memantine 30mg | — | 0/16 (0%) | 8/16 (50%) |
| Event | Memantine 10mg | Memantine 20mg | Memantine 30mg |
|---|---|---|---|
| Lethargic or tiredGeneral disorders | 0/29 | 1/24 | 3/16 |
| Light-headed/dizzyGeneral disorders | 2/29 | 4/24 | 2/16 |
| NauseaGeneral disorders | 0/29 | 0/24 | 2/16 |
| HeadacheGeneral disorders | 3/29 | 0/24 | 0/16 |
| Decreased libidoGeneral disorders | 0/29 | 1/24 | 1/16 |
| Age, Categorical(Participants) | Memantine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 28 |
| >=65 years | 1 |
| Age Continuous(years) | Memantine |
|---|---|
| Mean | 50.4 ± 13 |
| Sex: Female, Male(Participants) | Memantine |
|---|---|
| Female | 18 |
| Male | 11 |
| Race (NIH/OMB)(Participants) | Memantine |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 23 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Memantine |
|---|---|
| United States | 29 |
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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