Trial Outcomes & Findings for Memantine Treatment Study of Pathological Gambling (NCT NCT00585169)

Last Updated: 2013-04-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

Baseline to study end point (10 weeks)

Results posted on

2013-04-08

Participant Flow

Men and women with a primary diagnosis of Pathological Gambling (PG) were recruited between April 2008 through February 2010

Twenty-eight of the 29 enrolled subjects completed the study with only one subject withdrawing due to time constraints

Participant milestones

Participant milestones
Measure	Memantine 10 to 30 mg/day memantine Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day
Overall Study STARTED	29
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Memantine 10 to 30 mg/day memantine Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Memantine Treatment Study of Pathological Gambling

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Memantine n=29 Participants 10 to 30 mg/day memantine Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age Continuous	50.4 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to study end point (10 weeks)

Population: All participants who completed at least one study visit were included in the analysis.

Outcome measures

Outcome measures
Measure	Memantine n=29 Participants 10 to 30 mg/day memantine Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day
Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) Baseline	21.8 units on a scale Standard Deviation 4.3
Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS) 10 weeks	8.9 units on a scale Standard Deviation 7.2

Adverse Events

Memantine 10mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Memantine 20mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Memantine 30mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Memantine 10mg n=29 participants at risk	Memantine 20mg n=24 participants at risk	Memantine 30mg n=16 participants at risk
General disorders Light-headed/dizzy	6.9% 2/29	16.7% 4/24	12.5% 2/16
General disorders Headache	10.3% 3/29	0.00% 0/24	0.00% 0/16
General disorders Lethargic or tired	0.00% 0/29	4.2% 1/24	18.8% 3/16
General disorders Decreased libido	0.00% 0/29	4.2% 1/24	6.2% 1/16
General disorders Nausea	0.00% 0/29	0.00% 0/24	12.5% 2/16

Additional Information

Marc N. Potenza, M.D., Ph.D.

Yale Unviersity

Phone: 203-737-3553

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place