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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


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.


Minimum age: 5 Years. Maximum age: 14 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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