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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Men and women with a primary diagnosis of Pathological Gambling (PG) were recruited between April 2008 through February 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Twenty-eight of the 29 enrolled subjects completed the study with only one subject withdrawing due to time constraints

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Memantine
STARTED   29 
COMPLETED   28 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Baseline Measures
   Memantine 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   28 
>=65 years   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.4  (13) 
Gender 
[Units: Participants]
 
Female   18 
Male   11 
Race (NIH/OMB) 
[Units: Participants]
 
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 
[Units: Participants]
 
United States   29 


  Outcome Measures

1.  Primary:   Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)   [ Time Frame: Baseline to study end point (10 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: marc.potenza@yale.edu


Publications of Results:

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