Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.

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

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Dexmethylphenidate Hydrochloride; Guanfacine; Methylphenidate

Criteria

Inclusion Criteria:

• Diagnosis of DSM-IV ADHD by K-SADS-PL and confirmed by clinical interview

• Clinical Global Impression-Severity score of at least 4 for ADHD

• Resided with primary caretaker for at least 6 months prior to study entry

Exclusion Criteria:

• History of autism, pervasive developmental disorder, chronic tic disorder, psychosis, or bipolar disorder

• Current major depression or panic disorder

• Systolic or diastolic blood pressure at screening greater than the 95th percentile or less than the 5th percentile for age and body mass index (BMI)

• Any medical condition that might make stimulant or alpha agonist therapy medically inadvisable

• Need for chronic use of other medications with central nervous system effects

• Pregnant, breastfeeding, or beyond menarche and has a positive urine pregnancy test

• History of structural heart defects, syncope, or fainting while exercising

• Clinically significant cardiac abnormality as determined by echocardiogram (ECG) at study entry

• Mental retardation as determined by clinical functional assessment and an IQ estimate of less than 70 based on Wechsler Adult Intelligence Scale (WAIS) subtests