- Male or female from 6 to 12 years of age at the time of screening, inclusive.
- Diagnosis of ADHD by a Psychiatrist, Psychologist, Developmental Pediatrician, or a
Pediatrician meeting diagnostic criteria for ADHD (DSM-IV). A Schedule for Affective
Disorders and Schizophrenia for School Age Children (K-SADS)16 was administered on
all subjects to assist in diagnostic process.
- A clinician-administered Clinical Global Impression of Severity (CGI-S) score of 3 or
greater. An Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) score at
screening or baseline greater than or equal to the 90th percentile normative values
for gender and age in at least one of the following categories: the
hyperactive-impulsive subscale, inattentive subscale or the total score.
- Subject must have been in need of pharmacological treatment for ADHD.
- Subjects taking a medication to control ADHD at the time of screening must have been
experiencing suboptimal efficacy, a safety or tolerability issue or in need of a
long-acting liquid formulation.
- For subjects taking any daily medication at screening aside from ADHD medication:
parent or legal guardian agreed that there would be no elective changes in subject's
medications during the study (10 weeks total).
- Excluded comorbid psychiatric diagnoses: DSM-IV Axis I diagnosis (active) other than
ADHD, with the exception of Specific Phobias, Learning Disorders, Motor Skills
Disorders, Communication Disorders, Oppositional Defiant Disorder, Elimination
Disorders, Sleep Disorders, and Adjustment Disorders.
- Clinically significant cognitive impairment as assessed in the clinical judgment of
the Investigator. In cases where this was not clear, study staff were permitted to
administer a Wechsler Abbreviated Scale of Intelligence (WASI)17 to estimate the
intelligence quotient (IQ). Significant cognitive impairment for this protocol was
defined as an estimated IQ below 80.
- Subjects with chronic medical illnesses including seizure disorder (excluding a
history of febrile seizures), severe hypertension, thyroid disease, structural
cardiac disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy,
glaucoma, Tourette's Disorder, family history of Tourette's Disorder or tics.
- Use of monoamine oxidase inhibitors within 30 days of the screening visit.
- Use of any psychotropic medication (except sedative hypnotics prescribed as a sleep
aid at a stable dose for at least 30 days prior to screening, at bedtime only). Use
of stimulant medication for control of ADHD at screening was permitted if inclusion
criterion number 6 was met.