Long Acting Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Young Children
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: methylphenidate
Intervention description: Starting dose: methylphenidate (immediate-release pill) or Methylin (immediate-release chewable tablet for those unable to swallow pills) 2.5mg Q AM and Q noon. Target dose of 1mg/kg/day. Titration will occur as follows: 5mg Q AM and Q noon, then 7.5mg Q AM and Q noon, then 10mg Q AM and Q noon, as tolerated, not to exceed 30mg per day. Once each child arrives at a stable dose with a good response and good tolerability, they will be converted to the closest Ritalin LA dose, with a target dose of 1mg/kg/day.
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 4 Years
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Attention Deficit Hyperactivity Disorder; Stimulant Treatment; Young Children

Summary:

      This is a pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in
      treating Attention Deficit Hyperactivity Disorder (ADHD) in 4 and 5 year old children.
      Virtually no data has been published on the use of long-acting stimulant preparations in very
      young children despite early symptomatic development in a significant portion of young
      children with ADHD. This would be one of the first studies looking at a long-acting
      preparation of a stimulant medication in the treatment of ADHD in very young children.

      Hypotheses

        1. Ritalin LA is effective for the treatment of ADHD in 4 and 5 year old children.

        2. Ritalin LA is reasonably well-tolerated in the treatment of ADHD in 4 and 5 year old
           children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained from the legal guardian.

          -  Parent and child must be English-speaking.

          -  The child must have been living with the parent or guardian for a minimum of 6 months
             at the time of study entry.

          -  Age: 4-5 years of age at study entry.

          -  weight of at least 15kg (20th percentile for 4 year olds) for boys and weight of at
             least 14.5kg (20th percentile for 4 year olds) for girls

          -  Severity: age and sex-adjusted T score greater or equal to 65 on the Hyperactive-
             Impulsive Subscale of both the Conners Parent and Teacher Rating Scales (L)

          -  Diagnosis: meets DSM-IV criteria for ADHD (hyperactive/impulsive or combined subtype),
             on Parent Diagnostic Interview Schedule for Children-IV (DISC-IV) and clinical
             interview by experienced clinician. ADHD must be the primary disorder.

          -  Duration: symptoms must have been present for a minimum of nine months.

          -  Impairment: less than or equal to 55 on the Child Global Assessment Scale.

          -  Cognitive functioning: An estimated IQ 70 or greater on the Peabody Picture Vocabulary
             Test (PPVT).

          -  School: participation in school-type program at least 2 half-days per week where class
             includes at least 8 peers; if child has been expelled from an eligible program in the
             3 months before screening, they can be considered for enrollment as this may reflect
             severity of the disorder

          -  Parents and patients must be able to attend regular study visits.

          -  Children being treated with other stimulant or non-stimulant medications prior to
             enrollment will be allowed to discontinue treatment with these medications in order to
             enter the study, providing the parent wants to do so to enable their child to have a
             trial of Ritalin LA, the target symptoms are not well-controlled or unwanted side
             effects are persisting on their current treatment, and the prescribing physician is
             notified by the parent. These children will have a visit 1A in order to accommodate a
             5 half-lives washout of their pre-study medication.

        Exclusion Criteria:

          -  Other medications: no concurrent psychotropic medications or other medications
             (including herbal preparations and over-the-counter medications) with significant CNS
             effects (e.g., antidepressants, antipsychotics, drugs affecting blood pressure or
             heart rate, anticonvulsants, alpha-agonists, adrenergic blockers, lithium, or sedating
             antihistamines).

          -  General medical conditions: children with major medical conditions that would
             interfere with involvement in the study or the study medication will not be enrolled.

          -  Serious structural cardiac abnormalities: The recent joint advisory of the American
             Academy of Pediatrics (AAP) and the American Heart Association (AHA) recommend use of
             stimulant medications should generally be avoided in patients with cardiomyopathy,
             serious heart rhythm or structural abnormalities, or other serious cardiac problems.
             Any patient with such a diagnosis will not be allowed in this study.

          -  Systolic and diastolic blood pressure above 95th percentile for age and gender

          -  Exclusionary Psychiatric Conditions: Current Adjustment Disorder, Autism, Psychosis,
             Bipolar Disorder, PTSD, significant suicidality, or any other psychiatric disorder in
             addition to ADHD that requires treatment with additional medications.

          -  History of physical, sexual, or emotional abuse that results in a clinically
             significant impact on clinical presentation, potentially driving some of the symptoms
             of ADHD.

          -  Prior failure to respond to an adequate trial of any methylphenidate product. This
             will be at the determination of the investigator.