Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Quillivant Oral Suspension XR; Placebo; Placebo
Intervention description: Oral Suspension 25mg/5mL; 20-60 mg/day; Matching Placebo Oral Suspension 25mg/5mL; 20-60 mg/day; Matching placebo was a solution that was identical in taste and appearance to the Active drug that was used in this study.
Intervention MeSH terms: Methylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Hyperactivity Attention Deficit Disorder; ADHD; Pediatric Patients; Quillivant; methylphenidate

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.