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Long-Duration Stimulant Treatment Study of ADHD in Young Children (B-MPH)

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
B-MPH
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, Attention-deficit/hyperactivity disorder (ADHD)

Eligibility Criteria

4 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Parents/guardians and children must speak English and/or Spanish; parents/guardians must sign consent form; children must verbally assent. Boys and girls from 4-5 years old (inclusive) at screening. Children who meet the DSM-IV criteria for a primary diagnosis of ADHD (combined or hyperactive subtype), with symptoms present for at least 9 months. Children who demonstrate adequate need for treatment due to ADHD symptom-severity and clinical impairment. Children with IQ of at least 70 confirmed by valid IQ test. Children who are in educational settings (pre-school, kindergarten, or elementary school program) with at least 8 same-age peers for at least two half days weekly. Parents and children who can attend weekly study visits. Children who are naïve to ADHD medications; received ADHD medications in the past but are not currently treated; or on ADHD medications but finding them inconvenient (due to short duration of action) or not very helpful Exclusion Criteria: Children and parents/guardians who do not understand or cannot follow necessary instructions; children and parents who are unwilling to comply with study procedures or cooperate with child psychiatrist. Children taking excluded medications. Children with history of intolerance to MPH/stimulant medications or no response to adequate stimulant trials. Children with current adjustment disorder, autism, psychosis, bipolar disorder, significant suicidality, or other psychiatric disorders. Children with history of physical, sexual, or emotional abuse, which lead to a significant impact on the clinical presentation and potentially some ADHD symptoms. Children with screening abnormalities deemed clinically significant by child psychiatrist.

Sites / Locations

  • New York State Psychiatric Insitute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADHD Treatment Group

Arm Description

Single-arm, open-label, once-daily-dosing of long-duration beaded MPH (B-MPH) at 10-30 mg (flexible titration) in 4-to-5 year old children with ADHD.

Outcomes

Primary Outcome Measures

Swanson, Nolan, and Pelham Questionnaire (SNAP-IV)
The SNAP-IV Rating Scale is a revision of the Swanson, Nolan and Pelham (SNAP) Questionnaire (Swanson et al, 1983). The SNAP-IV is based on a 0 to 3 rating scale: Not at All = 0, Just A Little = 1, Quite A Bit = 2, and Very Much = 3. Subscale scores on the SNAP-IV are calculated by summing the scores on the items in the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item, as shown for ratings on the ADHD-Inattentive (ADHD-I) subset. Sub scale ranges from 0-3. Higher scores mean better outcome. Change score from baseline is reported.
Clinical Global Impressions-Severity (CGI-S)
CGI-S is designed to assess severity of illness on a seven-point scale: 1 = normal (not at ll ill) to 7 = among the most extremely ill patients. Range: 0-7, higher score means worse outcome. Change from baseline is reported.
Children's Global Assessment Scale (C-GAS)
Children's Global Assessment Scale (C-GAS) is designed to assess overall functioning across settings. The scale is rated from 1 to 100, with lower scores reflecting poorer adjustment. Change from baseline is reported.

Secondary Outcome Measures

Full Information

First Posted
November 21, 2005
Last Updated
August 14, 2020
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00257725
Brief Title
Long-Duration Stimulant Treatment Study of ADHD in Young Children
Acronym
B-MPH
Official Title
Long-Duration Stimulant Treatment of ADHD in Young Children-Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in 4-to-5-year olds.
Detailed Description
This is a single site, open-label, four-week feasibility study of long-duration beaded methylphenidate (B-MPH), also known as Ritalin LA™. B-MPH is a FDA-approved medication for children 6 years and older with attention-deficit/hyperactivity disorder (ADHD), but there are no studies of its use in preschoolers. This study will evaluate the safety and effectiveness of B-MPH for ADHD treatment in 4-to-5-year old children. Total study duration is approximately 5 weeks. It includes a screening evaluation and 4 weeks of B-MPH treatment with doses ranging from 10 to 30 mg (based on the individual tolerability and efficacy). The study doctor will conduct parent-training sessions during the treatment visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
ADHD, Attention-deficit/hyperactivity disorder (ADHD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADHD Treatment Group
Arm Type
Experimental
Arm Description
Single-arm, open-label, once-daily-dosing of long-duration beaded MPH (B-MPH) at 10-30 mg (flexible titration) in 4-to-5 year old children with ADHD.
Intervention Type
Drug
Intervention Name(s)
B-MPH
Other Intervention Name(s)
Ritalin LA
Intervention Description
Dosage form is a 20 mg capsule to be given once daily in the morning for 30 days
Primary Outcome Measure Information:
Title
Swanson, Nolan, and Pelham Questionnaire (SNAP-IV)
Description
The SNAP-IV Rating Scale is a revision of the Swanson, Nolan and Pelham (SNAP) Questionnaire (Swanson et al, 1983). The SNAP-IV is based on a 0 to 3 rating scale: Not at All = 0, Just A Little = 1, Quite A Bit = 2, and Very Much = 3. Subscale scores on the SNAP-IV are calculated by summing the scores on the items in the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item, as shown for ratings on the ADHD-Inattentive (ADHD-I) subset. Sub scale ranges from 0-3. Higher scores mean better outcome. Change score from baseline is reported.
Time Frame
week 5
Title
Clinical Global Impressions-Severity (CGI-S)
Description
CGI-S is designed to assess severity of illness on a seven-point scale: 1 = normal (not at ll ill) to 7 = among the most extremely ill patients. Range: 0-7, higher score means worse outcome. Change from baseline is reported.
Time Frame
week 5
Title
Children's Global Assessment Scale (C-GAS)
Description
Children's Global Assessment Scale (C-GAS) is designed to assess overall functioning across settings. The scale is rated from 1 to 100, with lower scores reflecting poorer adjustment. Change from baseline is reported.
Time Frame
week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Parents/guardians and children must speak English and/or Spanish; parents/guardians must sign consent form; children must verbally assent. Boys and girls from 4-5 years old (inclusive) at screening. Children who meet the DSM-IV criteria for a primary diagnosis of ADHD (combined or hyperactive subtype), with symptoms present for at least 9 months. Children who demonstrate adequate need for treatment due to ADHD symptom-severity and clinical impairment. Children with IQ of at least 70 confirmed by valid IQ test. Children who are in educational settings (pre-school, kindergarten, or elementary school program) with at least 8 same-age peers for at least two half days weekly. Parents and children who can attend weekly study visits. Children who are naïve to ADHD medications; received ADHD medications in the past but are not currently treated; or on ADHD medications but finding them inconvenient (due to short duration of action) or not very helpful Exclusion Criteria: Children and parents/guardians who do not understand or cannot follow necessary instructions; children and parents who are unwilling to comply with study procedures or cooperate with child psychiatrist. Children taking excluded medications. Children with history of intolerance to MPH/stimulant medications or no response to adequate stimulant trials. Children with current adjustment disorder, autism, psychosis, bipolar disorder, significant suicidality, or other psychiatric disorders. Children with history of physical, sexual, or emotional abuse, which lead to a significant impact on the clinical presentation and potentially some ADHD symptoms. Children with screening abnormalities deemed clinically significant by child psychiatrist.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence L Greenhill, MD
Organizational Affiliation
New York State Psychiatric Insitute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Insitute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19374023
Citation
Maayan L, Paykina N, Fried J, Strauss T, Gugga SS, Greenhill L. The open-label treatment of attention-deficit/hyperactivity disorder in 4- and 5-year-old children with beaded methylphenidate. J Child Adolesc Psychopharmacol. 2009 Apr;19(2):147-53. doi: 10.1089/cap.2008.053.
Results Reference
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Long-Duration Stimulant Treatment Study of ADHD in Young Children

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