Methylphenidate Study in Young Children With Developmental Disorders

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if methylphenidate (a common brand name is Ritalin), a medicine used for treating older children with Attention Deficit and Hyperactivity Disorder (ADHD), is also safe and helpful for problems related to symptoms of ADHD in young children with Developmental Disorders (DD)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• 36-84 month old children

• Child must meet the DSM-IV criteria for AD or PDD NOS as determined via a parent interview on the ADI-R and on child observation via the ADOS, or DD.

• Child must have categorical and dimensional evidence of clinically significant ADHD symptoms in multiple settings that have been present for at least six months

Exclusion Criteria:

• Child with prior failed treatment with an adequate trial of methylphenidate;

• Concurrent treatment with other medications that have CNS effects or that affect performance (e.g., antidepressants, antipsychotics, alpha-agonists, adrenergic blockers, lithium carbonate, sedating antihistamines, decongestant or sympathomimetics);

• Child with a current history of chronic tic disorder (e.g., Tourette syndrome with current severity of moderate or more), or a family history of Tourette's Disorder. Children with chronic mild tics will be eligible for the study;

• Child who has a major medical condition that would interfere with involvement in the study or would be affected negatively by methylphenidate (i.e., heart disease, high blood pressure, glaucoma, untreated or unstable hyperthyroidism, uncontrolled seizure disorder, or illnesses that would require hospitalization). Children with seizures will be eligible for the study if the seizure medication is stable for 3 months and the child is seizure-free for at least 6 months;

• Child with co-morbid psychiatric diagnoses of Major Depression, Bipolar Disorder, a psychotic disorder, Rett's Disorder, Childhood Disintegrative Disorder, or other psychiatric disorders in addition to PDD and ADHD that may require treatment with additional/alternative medication;

• Current history of physical, sexual, or emotional abuse;

• The patient has taken an investigational drug within the last 30 days.