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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

4 weeks

Results posted on

2014-09-18

Participant Flow

Dates of recruitment period are: April 2010-July 2010 Location: Outpatient clinic

Participant milestones

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

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 weeks

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.

Outcome measures

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 weeks

Patients 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

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 events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: (646) 774-8061

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place