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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01100268
Other study ID # 6133
Secondary ID
Status Completed
Phase Phase 2
First received April 5, 2010
Last updated September 10, 2014
Start date April 2010
Est. completion date April 2011

Study information

Verified date August 2014
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Institute of Living Hartford Connecticut
United States New York State Psychiatric Insitute New York New York

Sponsors (2)

Lead Sponsor Collaborator
New York State Psychiatric Institute Hartford Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks No
Secondary 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. 4 weeks No
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