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Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Last updated on March 11, 2019

Study Location
UC Irvine Child Development Center
Irvine, California, 92612 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Attention Deficit Hyperactivity Disorder
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-12 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)


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