Enhancing Attention in Adults With Compulsive Hoarding

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01100268
• Collaborator: Hartford Hospital (Other)
• Enrollment: 4
• Locations: 2
• Arm: 1
• Duration (Months): 12
• Patients Per Site: 2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hoarding Disorder	Drug: Methylphenidate ER	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Enhancing Attention in Adults With Compulsive Hoarding: A Pilot Study
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

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.	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 Names: Concerta

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Institute of Living	Hartford	Connecticut	United States	06106
2	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Columbia University Obsessive-Compulsive Disorder Clinic

Publications

• 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.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT01100268
• Other Study ID Numbers: 6133
• First Posted: Apr 8, 2010
• Last Update Posted: Sep 18, 2014
• Last Verified: Aug 1, 2014

• Keywords provided by New York State Psychiatric Institute: Hoarding
• Additional relevant MeSH terms: Hoarding Disorder; Methylphenidate

Study Results

Participant Flow

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

Arm/Group Title	Methylphenidate ER
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

Baseline Characteristics

Arm/Group Title	Methylphenidate ER
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 Participants	4
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	4 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43 (5)
Sex: Female, Male (Count of Participants)
Female	3 75%
Male	1 25%
Region of Enrollment (participants) [Number]
United States	4 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methylphenidate ER
Arm/Group Description	Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
Measure Participants	4
Number [participants]	4 100%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Methylphenidate ER
Arm/Group Description	Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
Measure Participants	4
Number [participants]	2 50%

Adverse Events

Time Frame	3 months
Arm/Group Title	Methylphenidate ER
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Methylphenidate ER
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Other (Not Including Serious) Adverse Events
	Methylphenidate ER
	Affected / at Risk (%)	# Events
Total	0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.