Memantine in the Treatment of Kleptomania

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT00880685
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 39
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The goal of the proposed study is to evaluate the efficacy and safety of memantine in kleptomania.

Condition or Disease	Intervention/Treatment	Phase
Kleptomania	Drug: Memantine	Phase 2

Detailed Description

The proposed study will consist of 8 weeks of treatment with memantine in 10 subjects with kleptomania. The hypothesis to be tested is that memantine will be effective in reducing the urges to steal in patients with kleptomania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Memantine Treatment of Kleptomania: An Open-Label Study
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Memantine Memantine 10-30mg	Drug: Memantine; 10-30mg, daily for 8 weeks; Other Names: Namenda

Outcome Measures

Primary Outcome Measures

1. Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS) [Week 8 (last visit)]

   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.

Secondary Outcome Measures

1. Kleptomania Symptom Assessment Scale (K-SAS) [Week 8 (last visit)]

   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.

2. Clinical Global Impression Severity Scales (CGI) [Week 8 (last visit)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. men and women age 18-65

2. current KM using the clinician-administered Structured Clinical Interview for Kleptomania (SCI-K)

3. stealing behavior within 2 weeks prior to enrollment.

Exclusion Criteria:

1. infrequent stealing (i.e. less than one time per week) that does not meet proposed criteria for kleptomania (KM)

2. unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screen

3. history of seizures

4. myocardial infarction within 6 months

5. current pregnancy or lactation, or inadequate contraception in women of childbearing potential

6. a need for medication other than memantine with possible psychotropic effects or unfavorable interactions

7. clinically significant suicidality

8. current Axis I disorder determined by the Structured Clinical Interview for the DSM (SCID) and SCID-compatible modules for impulse control disorders (Grant et al., 2005), except for nicotine dependence

9. lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any psychotic disorder determined by SCID

10. current or recent (past 3 months) DSM-IV substance abuse or dependence

11. positive urine drug screen at screening

12. initiation of psychotherapy or behavior therapy within 3 months prior to study baseline

13. previous treatment with memantine; and 14) treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55454

Sponsors and Collaborators

• University of Chicago

Investigators

• Principal Investigator: Jon E Grant, MD, JD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT00880685
• Other Study ID Numbers: 0901M56882
• First Posted: Apr 14, 2009
• Last Update Posted: May 24, 2021
• Last Verified: Apr 1, 2021

• Keywords provided by University of Chicago: Compulsive Stealing; Compulsive Shoplifting
• Additional relevant MeSH terms: Disruptive, Impulse Control, and Conduct Disorders; Memantine

Study Results

Participant Flow

Arm/Group Title	Memantine 10mg-30mg
Arm/Group Description	Memantine 10mg-30mg (active drug)
Period Title: Memantine 10mg
STARTED	12
COMPLETED	10
NOT COMPLETED	2
Period Title: Memantine 10mg
STARTED	10
COMPLETED	9
NOT COMPLETED	1
Period Title: Memantine 10mg
STARTED	9
COMPLETED	9
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Memantine 10mg-30mg
Arm/Group Description	Memantine 10mg-30mg (active drug)
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	12 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.6 (11.6)
Sex: Female, Male (Count of Participants)
Female	10 83.3%
Male	2 16.7%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS)
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Memantine 10mg-30mg
Arm/Group Description	Memantine 10mg-30mg (study drug)
Measure Participants	12
Mean (Standard Deviation) [units on a scale]	5.4 (4.2)

2. Secondary Outcome

Title	Kleptomania Symptom Assessment Scale (K-SAS)
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Memantine
Arm/Group Description	Memantine 10-30mg Memantine: 10-30mg, daily for 8 weeks
Measure Participants	12
Mean (Standard Deviation) [units on a scale]	12.3 (9.5)

3. Secondary Outcome

Title	Clinical Global Impression Severity Scales (CGI)
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Memantine 10mg-30mg
Arm/Group Description	Memantine 10mg-30mg (study drug)
Measure Participants	12
Mean (Standard Deviation) [units on a scale]	2.2 (1.0)

Adverse Events

Time Frame	Adverse events were collected from the beginning of the study until study completion (3 years)
Arm/Group Title	Memantine 10mg		Memantine 20mg		Memantine 30mg
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Memantine 10mg		Memantine 20mg		Memantine 30mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/10 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Memantine 10mg		Memantine 20mg		Memantine 30mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/12 (25%)		4/10 (40%)		2/9 (22.2%)
Gastrointestinal disorders
Nausea	0/12 (0%)		1/10 (10%)		0/9 (0%)
General disorders
Dry Mouth	0/12 (0%)		1/10 (10%)		0/9 (0%)
Dizziness	1/12 (8.3%)		1/10 (10%)		1/9 (11.1%)
Metabolism and nutrition disorders
Increased Appetite	0/12 (0%)		0/10 (0%)		1/9 (11.1%)
Nervous system disorders
Headache	2/12 (16.7%)		0/10 (0%)		0/9 (0%)
Psychiatric disorders
Anxiety	0/12 (0%)		1/10 (10%)		0/9 (0%)

Limitations/Caveats

[Not Specified]

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.