quillivant oral suspension (quillivant xr) in the treatment of attention deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the objective of this study was to establish that an optimal dose of quillivant xr oral suspension would result in a significant reduction in signs and symptoms of adhd compared to placebo treatment in pediatric patients ages 6-12 years with adhd.


Eligibility criteria:
inclusion criteria: * 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). exclusion criteria: * 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.

Keywords: hyperactivity attention deficit disorder adhd pediatric patients quillivant methylphenidate