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Completed

NCT Number: NCT00257725

Long-Duration Stimulant Treatment Study of ADHD in Young Children

This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in 4-to-5-year olds.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

4 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York State Psychiatric Insitute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

B-MPH

Drug

Dosage form is a 20 mg capsule to be given once daily in the morning for 30 days

Other names: Ritalin LA

Primary outcomes

  1. Swanson, Nolan, and Pelham Questionnaire (SNAP-IV)

    Time frame: 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.

  2. Clinical Global Impressions-Severity (CGI-S)

    Time frame: 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.

  3. Children's Global Assessment Scale (C-GAS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Official study title

Long-Duration Stimulant Treatment of ADHD in Young Children-Feasibility Study

Acronym: B-MPH

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Nov 23, 2005
Registry last updated
Aug 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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