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Enhancing Attention in Adults With Compulsive Hoarding

Primary Purpose

Hoarding Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate ER
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hoarding Disorder focused on measuring Hoarding

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically significant compulsive hoarding (Proposed DSM-V criteria) that is principal (i.e. currently most severe and needing of treatment) and has been present for at least one year.
  • At least moderate attentional difficulties.
  • Able to provide consent.
  • Patients can be on or off of serotonin reuptake inhibitors (SRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs) but dose must be stable for 12 weeks prior to study.

Exclusion Criteria:

  • Currently taking any psychotropic medications other than SRIs or SNRIs.
  • Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder or other psychotic disorder.
  • Current major depression is permitted if clearly secondary in importance to the hoarding.
  • Judged clinically to be at risk of suicide (suicidal ideation, severe depression or other factors)
  • Any cardiovascular abnormality that increases the risk of participation, including significant history of cardiovascular disease or family history of sudden death.
  • Any medical or neurological disorder that increases the risk of participation or that is a medical contraindication for taking methylphenidate (e.g. glaucoma or Tourette's syndrome).
  • Current use of any drug that is contraindicated with methylphenidate (e.g. monoamine oxidase inhibitors).
  • Female patients who are pregnant or nursing.
  • Current or previous treatment with methylphenidate or CBT for hoarding.
  • Current ETOH/drug abuse or dependence disorder of dependency in the past 6 months.
  • Individuals with mild cognitive impairments, dementia, or significant intellectual deficits.

Sites / Locations

  • Institute of Living
  • New York State Psychiatric Insitute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Methylphenidate ER

Arm Description

Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.

Outcomes

Primary Outcome Measures

Number of Patients Who Met and Exceeded Response Criteria of Attention Deficit Hyperactivity Disorder Symptom Scale
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.

Secondary Outcome Measures

Number of Patients Who Met Response Criteria for the Saving Inventory-Revised.
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.

Full Information

First Posted
April 5, 2010
Last Updated
September 10, 2014
Sponsor
New York State Psychiatric Institute
Collaborators
Hartford Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01100268
Brief Title
Enhancing Attention in Adults With Compulsive Hoarding
Official Title
Enhancing Attention in Adults With Compulsive Hoarding: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Hartford Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Available data suggest that compulsive hoarders have cognitive deficits, particularly with sustaining attention that might contribute their hoarding symptoms.
Detailed Description
Compulsive hoarders perform significantly worse than healthy controls on standard attention tasks. These data suggest that the inability to sustain focus may interfere with hoarders' ability to organize, categorize and make decisions about discarding possessions. Stimulants are first-line treatments for ADHD, improve CPT performance in people with ADHD and enhance school performance in children with ADHD. Extended release formulations, such as methylphenidate ER, are associated with better medication compliance. Together, these data suggest that adjunctive methylphenidate ER might be a novel way to improve attention in compulsive hoarders which might improve hoarding symptoms. The investigators hypothesis is that adjunctive methylphenidate ER will improve attention in compulsive hoarders aged 18-55. The investigators will also explore the safety of methylphenidate ER administration in compulsive hoarders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hoarding Disorder
Keywords
Hoarding

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylphenidate ER
Arm Type
Experimental
Arm Description
Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
Intervention Type
Drug
Intervention Name(s)
Methylphenidate ER
Other Intervention Name(s)
Concerta
Intervention Description
Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
Primary Outcome Measure Information:
Title
Number of Patients Who Met and Exceeded Response Criteria of Attention Deficit Hyperactivity Disorder Symptom Scale
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
Secondary Outcome Measure Information:
Title
Number of Patients Who Met Response Criteria for the Saving Inventory-Revised.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically significant compulsive hoarding (Proposed DSM-V criteria) that is principal (i.e. currently most severe and needing of treatment) and has been present for at least one year. At least moderate attentional difficulties. Able to provide consent. Patients can be on or off of serotonin reuptake inhibitors (SRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs) but dose must be stable for 12 weeks prior to study. Exclusion Criteria: Currently taking any psychotropic medications other than SRIs or SNRIs. Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder or other psychotic disorder. Current major depression is permitted if clearly secondary in importance to the hoarding. Judged clinically to be at risk of suicide (suicidal ideation, severe depression or other factors) Any cardiovascular abnormality that increases the risk of participation, including significant history of cardiovascular disease or family history of sudden death. Any medical or neurological disorder that increases the risk of participation or that is a medical contraindication for taking methylphenidate (e.g. glaucoma or Tourette's syndrome). Current use of any drug that is contraindicated with methylphenidate (e.g. monoamine oxidase inhibitors). Female patients who are pregnant or nursing. Current or previous treatment with methylphenidate or CBT for hoarding. Current ETOH/drug abuse or dependence disorder of dependency in the past 6 months. Individuals with mild cognitive impairments, dementia, or significant intellectual deficits.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn I. Rodriguez, M.D., Ph.D.
Organizational Affiliation
Columbia-NYSPI-RFMH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Living
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
New York State Psychiatric Insitute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23609401
Citation
Rodriguez CI, Bender J Jr, Morrison S, Mehendru R, Tolin D, Simpson HB. Does extended release methylphenidate help adults with hoarding disorder?: a case series. J Clin Psychopharmacol. 2013 Jun;33(3):444-7. doi: 10.1097/JCP.0b013e318290115e. No abstract available.
Results Reference
background
Links:
URL
http://www.columbia-ocd.org
Description
Columbia University Obsessive-Compulsive Disorder Clinic

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Enhancing Attention in Adults With Compulsive Hoarding

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