Trial Outcomes & Findings for Enhancing Attention in Adults With Compulsive Hoarding (NCT NCT01100268)
NCT ID: NCT01100268
Last Updated: 2014-09-18
Results Overview
Patients given Attention Deficit Hyperactivity Disorder Symptom Scale (ADHDSS), a measure of the features of Attention Deficit Hyperactivity Disorder including inattention, hyperactivity, and impulsivity. This scale has shown excellent reliability in prior studies of individuals with HD. For the ADHDSS the minimum units are 0 and Maximum units on the total scale are 54 (adult). The higher the number on the ADHDSS, the more severe the symptoms. Response was defined as at least a 30% reduction on the ADHDSS.
COMPLETED
PHASE2
4 participants
4 weeks
2014-09-18
Participant Flow
Dates of recruitment period are: April 2010-July 2010 Location: Outpatient clinic
Participant milestones
| Measure |
Methylphenidate ER
Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhancing Attention in Adults With Compulsive Hoarding
Baseline characteristics by cohort
| Measure |
Methylphenidate ER
n=4 Participants
Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPatients given Attention Deficit Hyperactivity Disorder Symptom Scale (ADHDSS), a measure of the features of Attention Deficit Hyperactivity Disorder including inattention, hyperactivity, and impulsivity. This scale has shown excellent reliability in prior studies of individuals with HD. For the ADHDSS the minimum units are 0 and Maximum units on the total scale are 54 (adult). The higher the number on the ADHDSS, the more severe the symptoms. Response was defined as at least a 30% reduction on the ADHDSS.
Outcome measures
| Measure |
Methylphenidate ER
n=4 Participants
Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
|
|---|---|
|
Number of Patients Who Met and Exceeded Response Criteria of Attention Deficit Hyperactivity Disorder Symptom Scale
|
4 participants
|
SECONDARY outcome
Timeframe: 4 weeksPatients given Saving Inventory-Revised (SI-R), an evidence-based measure of three features of hoarding: excessive acquisition, difficulty discarding, and clutter. For the SI-R the minimum units are 0 and Maximum units on the total scale are 92. The higher the number on the SI-R, the more severe the symptoms. Response was defined as at least a 25% reduction on the SI-R.
Outcome measures
| Measure |
Methylphenidate ER
n=4 Participants
Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
|
|---|---|
|
Number of Patients Who Met Response Criteria for the Saving Inventory-Revised.
|
2 participants
|
Adverse Events
Methylphenidate ER
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Carolyn Rodriguez
Columbia University Department of Psychiatry
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place