Enhancing Attention in Adults With Compulsive Hoarding

This study has been completed.
Sponsor:
Collaborator:
Hartford Hospital
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01100268
First received: April 5, 2010
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

Available data suggest that compulsive hoarders have cognitive deficits, particularly with sustaining attention that might contribute their hoarding symptoms.


Condition Intervention Phase
Hoarding Disorder
Drug: Methylphenidate ER
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Enhancing Attention in Adults With Compulsive Hoarding: A Pilot Study

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Number of Patients Who Met and Exceeded Response Criteria of Attention Deficit Hyperactivity Disorder Symptom Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 4
Study Start Date: April 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methylphenidate ER
Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
Drug: Methylphenidate ER
Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
Other Name: Concerta

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100268

Locations
United States, Connecticut
Institute of Living
Hartford, Connecticut, United States, 06106
United States, New York
New York State Psychiatric Insitute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Hartford Hospital
Investigators
Principal Investigator: Carolyn I. Rodriguez, M.D., Ph.D. Columbia-NYSPI-RFMH
  More Information

Additional Information:
Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01100268     History of Changes
Other Study ID Numbers: 6133
Study First Received: April 5, 2010
Results First Received: June 4, 2013
Last Updated: June 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Hoarding

Additional relevant MeSH terms:
Obsessive Hoarding
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014