NCT01100268

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

August 15, 2013

Completed
Last Updated

September 18, 2014

Status Verified

August 1, 2014

Enrollment Period

1 year

First QC Date

April 5, 2010

Results QC Date

June 4, 2013

Last Update Submit

September 10, 2014

Conditions

Keywords

Hoarding

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

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

    4 weeks

Study Arms (1)

Methylphenidate ER

EXPERIMENTAL

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

Drug: Methylphenidate ER

Interventions

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

Also known as: Concerta
Methylphenidate ER

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of Living

Hartford, Connecticut, 06106, United States

Location

New York State Psychiatric Insitute

New York, New York, 10032, United States

Location

Related 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. No abstract available.

    PMID: 23609401BACKGROUND

Related Links

MeSH Terms

Conditions

Hoarding DisorderHoarding

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Obsessive-Compulsive DisorderAnxiety DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Carolyn Rodriguez
Organization
Columbia University Department of Psychiatry

Study Officials

  • Carolyn I. Rodriguez, M.D., Ph.D.

    Columbia-NYSPI-RFMH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2010

First Posted

April 8, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

September 18, 2014

Results First Posted

August 15, 2013

Record last verified: 2014-08

Locations