Clinical trial NCT00257725: Long-Duration Stimulant Treatment Study of ADHD in Young Children
Official title: Long-Duration Stimulant Treatment of ADHD in Young Children-Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD
Attention-deficit/hyperactivity disorder (ADHD)
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2005-11-23
Enrollment: 11
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Parents/guardians and children must speak English and/or Spanish; parents/guardians must sign consent form; children must verbally assent.
2. Boys and girls from 4-5 years old (inclusive) at screening.
3. 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.
4. Children who demonstrate adequate need for treatment due to ADHD symptom-severity and clinical impairment.
5. Children with IQ of at least 70 confirmed by valid IQ test.
6. 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.
7. Parents and children who can attend weekly study visits.
8. 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:

1. 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.
2. Children taking excluded medications.
3. Children with history of intolerance to MPH/stimulant medications or no response to adequate stimulant trials.
4. Children with current adjustment disorder, autism, psychosis, bipolar disorder, significant suicidality, or other psychiatric disorders.
5. Children with history of physical, sexual, or emotional abuse, which lead to a significant impact on the clinical presentation and potentially some ADHD symptoms.
6. Children with screening abnormalities deemed clinically significant by child psychiatrist.

Primary outcomes:
measure: Swanson, Nolan, and Pelham Questionnaire (SNAP-IV)
timeFrame: week 5
measure: Clinical Global Impressions-Severity (CGI-S)
timeFrame: week 5
measure: Children's Global Assessment Scale (C-GAS)
timeFrame: week 5
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Insitute
state: New York
Study officials:
affiliation: New York State Psychiatric Insitute
name: Laurence L Greenhill, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.