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

Last updated on March 11, 2019

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Study Location
UC Irvine Child Development Center
Irvine, California, 92612 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Attention Deficit Hyperactivity Disorder
Sex
Females and Males
Age
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.

NCT00904670
Pfizer
Completed
Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

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[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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