Memantine in the Treatment of Kleptomania

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Chicago
ClinicalTrials.gov Identifier:
NCT00880685
First received: March 18, 2009
Last updated: January 17, 2014
Last verified: January 2014
Results First Received: August 19, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Kleptomania
Intervention: Drug: Memantine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Memantine 10mg-30mg 10mg-30mg

Participant Flow for 3 periods

Period 1:   Memantine 10mg
    Memantine 10mg-30mg  
STARTED     12  
COMPLETED     10  
NOT COMPLETED     2  
Lost to Follow-up                 2  

Period 2:   Memantine 20mg
    Memantine 10mg-30mg  
STARTED     10  
COMPLETED     9  
NOT COMPLETED     1  
Withdrawal by Subject                 1  

Period 3:   Memantine 30mg
    Memantine 10mg-30mg  
STARTED     9  
COMPLETED     9  
NOT COMPLETED     0  



  Baseline Characteristics
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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 10mg-30mg 10mg-30mg

Baseline Measures
    Memantine 10mg-30mg  
Number of Participants  
[units: participants]
  12  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  46.6  ± 11.6  
Gender  
[units: participants]
 
Female     10  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures
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1.  Primary:   Yale Brown Obsessive Compulsive Scale Modified for KM (KM-YBOCS)   [ Time Frame: Week 8 (last visit) ]

2.  Secondary:   Kleptomania Symptom Assessment Scale (K-SAS)   [ Time Frame: Week 8 (last visit) ]

3.  Secondary:   Clinical Global Impression Severity Scales (CGI)   [ Time Frame: Week 8 (last visit) ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


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.  


Results Point of Contact:  
Name/Title: Dr. Jon Grant
Organization: University of Chicago
phone: 773-834-1326
e-mail: jongrant@uchicago.edu


No publications provided


Responsible Party: Jon Grant, University of Chicago
ClinicalTrials.gov Identifier: NCT00880685     History of Changes
Other Study ID Numbers: 0901M56882
Study First Received: March 18, 2009
Results First Received: August 19, 2013
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration