ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhancing Attention in Adults With Compulsive Hoarding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01100268
Recruitment Status : Completed
First Posted : April 8, 2010
Results First Posted : August 15, 2013
Last Update Posted : September 18, 2014
Sponsor:
Collaborator:
Hartford Hospital
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Hoarding Disorder
Intervention Drug: Methylphenidate ER
Enrollment 4
Recruitment Details Dates of recruitment period are: April 2010-July 2010 Location: Outpatient clinic
Pre-assignment Details  
Arm/Group Title Methylphenidate ER
Hide Arm/Group Description Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Methylphenidate ER
Hide Arm/Group Description Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
Individuals with Hoarding Disorder
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
43  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
3
  75.0%
Male
1
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Number of Patients Who Met and Exceeded Response Criteria of Attention Deficit Hyperactivity Disorder Symptom Scale
Hide Description 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.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylphenidate ER
Hide Arm/Group Description:
Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
4
2.Secondary Outcome
Title Number of Patients Who Met Response Criteria for the Saving Inventory-Revised.
Hide Description 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.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylphenidate ER
Hide Arm/Group Description:
Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
2
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methylphenidate ER
Hide Arm/Group Description Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
All-Cause Mortality
Methylphenidate ER
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Methylphenidate ER
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Methylphenidate ER
Affected / at Risk (%)
Total   0/4 (0.00%) 
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.
Results Point of Contact
Name/Title: Dr. Carolyn Rodriguez
Organization: Columbia University Department of Psychiatry
Phone: (646) 774-8061
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01100268     History of Changes
Other Study ID Numbers: 6133
First Submitted: April 5, 2010
First Posted: April 8, 2010
Results First Submitted: June 4, 2013
Results First Posted: August 15, 2013
Last Update Posted: September 18, 2014