Trial Outcomes & Findings for Memantine in the Treatment of Kleptomania (NCT NCT00880685)
NCT ID: NCT00880685
Last Updated: 2021-05-24
Results Overview
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.
COMPLETED
PHASE2
12 participants
Week 8 (last visit)
2021-05-24
Participant Flow
Participant milestones
| Measure |
Memantine 10mg-30mg
Memantine 10mg-30mg (active drug)
|
|---|---|
|
Memantine 10mg
STARTED
|
12
|
|
Memantine 10mg
COMPLETED
|
10
|
|
Memantine 10mg
NOT COMPLETED
|
2
|
|
Memantine 20mg
STARTED
|
10
|
|
Memantine 20mg
COMPLETED
|
9
|
|
Memantine 20mg
NOT COMPLETED
|
1
|
|
Memantine 30mg
STARTED
|
9
|
|
Memantine 30mg
COMPLETED
|
9
|
|
Memantine 30mg
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Memantine 10mg-30mg
Memantine 10mg-30mg (active drug)
|
|---|---|
|
Memantine 10mg
Lost to Follow-up
|
2
|
|
Memantine 20mg
Withdrawal by Subject
|
1
|
Baseline Characteristics
Memantine in the Treatment of Kleptomania
Baseline characteristics by cohort
| Measure |
Memantine 10mg-30mg
n=12 Participants
Memantine 10mg-30mg (active drug)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Memantine 10mg-30mg
n=12 Participants
Memantine 10mg-30mg (study drug)
|
|---|---|
|
Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (KM-YBOCS)
|
5.4 units on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Memantine 10mg-30mg
n=12 Participants
Memantine 10mg-30mg (study drug)
|
|---|---|
|
Kleptomania Symptom Assessment Scale (K-SAS)
|
12.3 units on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Memantine 10mg-30mg
n=12 Participants
Memantine 10mg-30mg (study drug)
|
|---|---|
|
Clinical Global Impression Severity Scales (CGI)
|
2.2 units on a scale
Standard Deviation 1.0
|
Adverse Events
Memantine 10mg
Memantine 20mg
Memantine 30mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Memantine 10mg
n=12 participants at risk
Memantine 10mg (study drug)
|
Memantine 20mg
n=10 participants at risk
Memantine 20mg (study drug)
|
Memantine 30mg
n=9 participants at risk
Memantine 30mg (study drug)
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
10.0%
1/10 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
0.00%
0/9 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
|
General disorders
Dry Mouth
|
0.00%
0/12 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
10.0%
1/10 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
0.00%
0/9 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/12 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
0.00%
0/10 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
11.1%
1/9 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/12 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
10.0%
1/10 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
0.00%
0/9 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
|
General disorders
Dizziness
|
8.3%
1/12 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
10.0%
1/10 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
11.1%
1/9 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
0.00%
0/10 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
0.00%
0/9 • Adverse events were collected from the beginning of the study until study completion (3 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place