A Phase 2 interventional study of Methylphenidate ER in Hoarding Disorder, sponsored by New York State Psychiatric Institute. Completed at 2 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2014-09-18.
Sponsored by New York State Psychiatric Institute · Phase 2, Interventional, and Diagnostic
Available data suggest that compulsive hoarders have cognitive deficits, particularly with sustaining attention that might contribute their hoarding symptoms.
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.
32 studies on the registry are indexed under Hoarding Disorder; 5 are open to participants now.
This study's enrollment of 4 is below the median of 37 across 28 interventional studies indexed under Hoarding Disorder.
Browse Hoarding Disorder studies →New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Concerta
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
Dates of recruitment period are: April 2010-July 2010 Location: Outpatient clinic
| Milestone | Methylphenidate ER |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
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.
| participants | Methylphenidate ER |
|---|---|
| Number of Patients Who Met and Exceeded Response Criteria of Attention Deficit Hyperactivity Disorder Symptom Scale | 4 |
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.
| participants | Methylphenidate ER |
|---|---|
| Number of Patients Who Met Response Criteria for the Saving Inventory-Revised. | 2 |
Collected over 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Methylphenidate ER | — | 0/4 (0%) | 0/4 (0%) |
Individuals with Hoarding Disorder
| Age, Categorical(Participants) | Methylphenidate ER |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 0 |
| Age, Continuous(years) | Methylphenidate ER |
|---|---|
| Mean | 43 ± 5 |
| Sex: Female, Male(Participants) | Methylphenidate ER |
|---|---|
| Female | 3 |
| Male | 1 |
| Region of Enrollment(participants) | Methylphenidate ER |
|---|---|
| United States | 4 |
The record gives a start of Apr 2010, a primary completion of Apr 2011 and a completion of Apr 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2013, 2 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methylphenidate
New York State Psychiatric Institute →