Long-Duration Stimulant Treatment Study of ADHD in Young Children

Phase 4

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
ADHD Treatment Group	B-MPH	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.

Primary Outcome Measures

Name	Time	Method
Clinical Global Impressions-Severity (CGI-S)	week 5	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)	week 5	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.
Swanson, Nolan, and Pelham Questionnaire (SNAP-IV)	week 5	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.