Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder
Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pervasive Development Disorders
Intervention: methylphenidate (Drug); placebo (Other); extended-release guanfacine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Yale University Official(s) and/or principal investigator(s): Lawrence Scahill, MSN, PhD, Principal Investigator, Affiliation: Emory University James McCracken, MD, Principal Investigator, Affiliation: University of California, Los Angeles Bryan King, MD, Principal Investigator, Affiliation: Seattle Children's Hospital Christopher McDougle, MD, Principal Investigator, Affiliation: Massachusetts General Hospital James Dziura, MPH, PhD, Principal Investigator, Affiliation: Yale University
Summary
The purpose of this study is to determine whether guanfacine (trade name Intuniv) by itself
or in combination with methylphenidate (also known as Ritalin) is helpful for treating
hyperactivity in children and adolescents with a Pervasive Developmental Disorders (PDDs).
Clinical Details
Official title: Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Aberrant Behavior Checklist Hyperactivity Subscale
Secondary outcome: ADHD Rating Scale
Detailed description:
Pervasive Developmental Disorders (PDDs) are a group of conditions that includes Autistic
Disorder, Asperger's disorder and so called Pervasive Developmental Disorder - Not Otherwise
Specified. Children with PDD show delays in speech and language and reduced social
interaction. Some children with PDD have also have problems with overactivity,
impulsiveness and distractability. These behaviors are seen in children with Attention
Deficit Hyperactivity Disorder (ADHD). Extended release guanfacine (Intuniv) is FDA-approved
for the treatment of children with ADHD. The purpose of this study is to evaluate whether
Intuniv is an effective treatment for ADHD symptoms in children with PDD.
This study has four parts: an 8-week double-blind trial, an 8-week blinded extension phase
(for positive responders only), an 8-week open-label trial, and a 4-week add-on study.
Following confirmation of eligibility, participants will be randomly assigned to receive
either guanfacine or placebo in the 8-week double-blind trial. Children who show
improvement after 8 weeks of treatment will continue on their assigned treatment for an
additional 8 weeks (blinded extension phase). Children who show partial improvement with
guanfacine will be offered 4 weeks of treatment with guanfacine plus methylphenidate (add-on
study). Children who show no improvement on placebo will be offered 8 weeks of treatment
with guanfacine (open-label trial). Children who show no improvement on guanfacine will exit
the study.
Side effects and treatment response will be assessed at regularly scheduled visits.
Eligibility
Minimum age: 5 Years.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of PDD (PDD-NOS, Asperger's Disorder, Autistic Disorder)
- Hyperactivity
- Between ages 5 years 0 months and 13 years 11 months.
- Weight >/= 15 kg (33 lb)
- A mental age of at least 18 months
Exclusion Criteria:
- Prior failed treatment with an adequate trial of guanfacine in the last 2 years
- Concurrent treatment with another psychoactive medication
Locations and Contacts
University of California, Los Angeles, Los Angeles, California 90024, United States
Yale University, New Haven, Connecticut 06519, United States
Emory University, Atlanta, Georgia 30329, United States
Massachusetts General Hospital, Lexington, Massachusetts 02142, United States
Seattle Children's Hospital, Seattle, Washington 98101, United States
Additional Information
Related publications: Scahill L, Aman MG, McDougle CJ, McCracken JT, Tierney E, Dziura J, Arnold LE, Posey D, Young C, Shah B, Ghuman J, Ritz L, Vitiello B. A prospective open trial of guanfacine in children with pervasive developmental disorders. J Child Adolesc Psychopharmacol. 2006 Oct;16(5):589-98.
Starting date: December 2011
Last updated: February 26, 2015
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