- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01100268
Enhancing Attention in Adults With Compulsive Hoarding
Enhancing Attention in Adults With Compulsive Hoarding: A Pilot Study
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Connecticut
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Hartford, Connecticut, United States, 06106
- Institute of Living
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New York
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New York, New York, United States, 10032
- New York State Psychiatric Insitute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Methylphenidate ER
Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
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Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Who Met and Exceeded Response Criteria of Attention Deficit Hyperactivity Disorder Symptom Scale
Time Frame: 4 weeks
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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.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Who Met Response Criteria for the Saving Inventory-Revised.
Time Frame: 4 weeks
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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.
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4 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Carolyn I. Rodriguez, M.D., Ph.D., Columbia-NYSPI-RFMH
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Anxiety Disorders
- Obsessive-Compulsive Disorder
- Hoarding Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Methylphenidate
Other Study ID Numbers
- 6133
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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