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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pathological Gambling
Intervention Drug: Memantine Hydrochloride
Enrollment 29
Recruitment Details Men and women with a primary diagnosis of Pathological Gambling (PG) were recruited between April 2008 through February 2010
Pre-assignment Details Twenty-eight of the 29 enrolled subjects completed the study with only one subject withdrawing due to time constraints
Arm/Group Title Memantine
Hide Arm/Group Description

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

Period Title: Overall Study
Started 29
Completed 28
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Memantine
Hide Arm/Group Description

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 Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
<=18 years
0
   0.0%
Between 18 and 65 years
28
  96.6%
>=65 years
1
   3.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants
50.4  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
18
  62.1%
Male
11
  37.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
American Indian or Alaska Native
2
   6.9%
Asian
2
   6.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   3.4%
White
23
  79.3%
More than one race
0
   0.0%
Unknown or Not Reported
1
   3.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants
29
1.Primary Outcome
Title Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who completed at least one study visit were included in the analysis.
Arm/Group Title Memantine
Hide Arm/Group Description:

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 Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 21.8  (4.3)
10 weeks 8.9  (7.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Memantine 10mg Memantine 20mg Memantine 30mg
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Memantine 10mg Memantine 20mg Memantine 30mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Memantine 10mg Memantine 20mg Memantine 30mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/24 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Memantine 10mg Memantine 20mg Memantine 30mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/29 (17.24%)   6/24 (25.00%)   8/16 (50.00%) 
General disorders       
Light-headed/dizzy   2/29 (6.90%)  4/24 (16.67%)  2/16 (12.50%) 
Headache   3/29 (10.34%)  0/24 (0.00%)  0/16 (0.00%) 
Lethargic or tired   0/29 (0.00%)  1/24 (4.17%)  3/16 (18.75%) 
Decreased libido   0/29 (0.00%)  1/24 (4.17%)  1/16 (6.25%) 
Nausea   0/29 (0.00%)  0/24 (0.00%)  2/16 (12.50%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Marc N. Potenza, M.D., Ph.D.
Organization: Yale Unviersity
Phone: 203-737-3553
Responsible Party: Marc Potenza, Yale University
ClinicalTrials.gov Identifier: NCT00585169     History of Changes
Other Study ID Numbers: 0705002703*
HIC 0705002703 ( Other Identifier: Yale University )
First Submitted: December 25, 2007
First Posted: January 3, 2008
Results First Submitted: January 29, 2013
Results First Posted: April 8, 2013
Last Update Posted: April 8, 2013