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Memantine in the Treatment of Kleptomania

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00880685
Recruitment Status : Completed
First Posted : April 14, 2009
Results First Posted : March 5, 2014
Last Update Posted : May 24, 2021
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Kleptomania
Intervention Drug: Memantine
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Memantine 10mg-30mg
Hide Arm/Group Description Memantine 10mg-30mg (active drug)
Period Title: Memantine 10mg
Started 12
Completed 10
Not Completed 2
Reason Not Completed
Lost to Follow-up             2
Period Title: Memantine 20mg
Started 10
Completed 9
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Period Title: Memantine 30mg
Started 9
Completed 9
Not Completed 0
Arm/Group Title Memantine 10mg-30mg
Hide Arm/Group Description Memantine 10mg-30mg (active drug)
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
46.6  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
10
  83.3%
Male
2
  16.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS)
Hide Description Scores could range from 0-40 with 0 being the least severe and 40 being the most severe. Here the total score was used. The Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS) was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported. The scale was given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.
Time Frame Week 8 (last visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Memantine 10mg-30mg
Hide Arm/Group Description:
Memantine 10mg-30mg (study drug)
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.4  (4.2)
2.Secondary Outcome
Title Kleptomania Symptom Assessment Scale (K-SAS)
Hide Description Scale used to measure severity of kleptomania. Scores could range from 0-36 with 0 being the least severe and 36 being the most severe. Here the total score was used. The K-SAS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported. The scale was given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.
Time Frame Week 8 (last visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Memantine
Hide Arm/Group Description:

Memantine 10-30mg

Memantine: 10-30mg, daily for 8 weeks
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.3  (9.5)
3.Secondary Outcome
Title Clinical Global Impression Severity Scales (CGI)
Hide Description The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.
Time Frame Week 8 (last visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Memantine 10mg-30mg
Hide Arm/Group Description:
Memantine 10mg-30mg (study drug)
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.2  (1.0)
Time Frame Adverse events were collected from the beginning of the study until study completion (3 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Memantine 10mg Memantine 20mg Memantine 30mg
Hide Arm/Group Description Memantine 10mg (study drug) Memantine 20mg (study drug) Memantine 30mg (study drug)
All-Cause Mortality
Memantine 10mg Memantine 20mg Memantine 30mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Memantine 10mg Memantine 20mg Memantine 30mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/10 (0.00%)   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Memantine 10mg Memantine 20mg Memantine 30mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/12 (25.00%)   4/10 (40.00%)   2/9 (22.22%) 
Gastrointestinal disorders       
Nausea †  0/12 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
General disorders       
Dry Mouth †  0/12 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
Dizziness †  1/12 (8.33%)  1/10 (10.00%)  1/9 (11.11%) 
Metabolism and nutrition disorders       
Increased Appetite †  0/12 (0.00%)  0/10 (0.00%)  1/9 (11.11%) 
Nervous system disorders       
Headache †  2/12 (16.67%)  0/10 (0.00%)  0/9 (0.00%) 
Psychiatric disorders       
Anxiety †  0/12 (0.00%)  1/10 (10.00%)  0/9 (0.00%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Dr. Jon Grant
Organization: University of Chicago
Phone: 773-834-1326
EMail: jongrant@uchicago.edu
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00880685    
Other Study ID Numbers: 0901M56882
First Submitted: March 18, 2009
First Posted: April 14, 2009
Results First Submitted: August 19, 2013
Results First Posted: March 5, 2014
Last Update Posted: May 24, 2021