Kleptomania
Conditions
Keywords
Compulsive Stealing, Compulsive Shoplifting
Brief summary
The goal of the proposed study is to evaluate the efficacy and safety of memantine in kleptomania.
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.
Interventions
DRUGMemantine
10-30mg, daily for 8 weeks
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Memantine 10mg-30mg Memantine 10mg-30mg (active drug) | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Memantine 10mg | Lost to Follow-up | 2 |
| Memantine 20mg | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Memantine 10mg-30mg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 46.6 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 12 | 4 / 10 | 2 / 9 |
| serious Total, serious adverse events | 0 / 12 | 0 / 10 | 0 / 9 |
Outcome results
Primary
Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS)
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memantine 10mg-30mg | Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS) | 5.4 units on a scale | Standard Deviation 4.2 |
Secondary
Clinical Global Impression Severity Scales (CGI)
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memantine 10mg-30mg | Clinical Global Impression Severity Scales (CGI) | 2.2 units on a scale | Standard Deviation 1 |
Secondary
Kleptomania Symptom Assessment Scale (K-SAS)
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memantine 10mg-30mg | Kleptomania Symptom Assessment Scale (K-SAS) | 12.3 units on a scale | Standard Deviation 9.5 |