Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Yale University
Sponsor:
Collaborators:
Emory University
Massachusetts General Hospital
Seattle Children's Hospital
University of California, Los Angeles
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01238575
First received: October 29, 2010
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention Phase
Pervasive Development Disorders
Drug: methylphenidate
Other: placebo
Drug: extended-release guanfacine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Aberrant Behavior Checklist Hyperactivity Subscale [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ADHD Rating Scale [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 112
Study Start Date: December 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extended-release guanfacine Drug: extended-release guanfacine
1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
Other Name: Intuniv
Placebo Comparator: Inactive placebo Other: placebo
Administered for up to 16 weeks.
Experimental: Methylphenidate add-on Drug: methylphenidate
5 mg tablets; flexible dosing up to 37.5 mg/day for up to 4 weeks in addition to extended release guanfacine.
Drug: extended-release guanfacine
1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
Other Name: Intuniv

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

Ages Eligible for Study:   5 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238575

Contacts
Contact: Lawrence Scahill, MSN, PhD lawrence.scahill@emory.edu

Locations
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90024
Contact: Jennifer Cowen, PhD    310-825-6170    jcowen@mednet.ucla.edu   
Principal Investigator: James McCracken, MD         
United States, Connecticut
Yale University Active, not recruiting
New Haven, Connecticut, United States, 06519
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30329
Contact: Christopher Page    404-785-8066    christopher.page@choa.org   
Principal Investigator: Lawrence Scahill, MSN, PhD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Lexington, Massachusetts, United States, 02142
Contact: Jennifer Mullett, RN, BC, CCRP    781-860-1710    jmullett@partners.org   
Principal Investigator: Christopher McDougle, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98101
Contact: Denise Ward, MA, LMHC, CCRC    206-884-1168    denise.ward@seattlechildrens.org   
Principal Investigator: Bryan King, MD         
Sponsors and Collaborators
Yale University
Emory University
Massachusetts General Hospital
Seattle Children's Hospital
University of California, Los Angeles
Investigators
Principal Investigator: Lawrence Scahill, MSN, PhD Emory University
Principal Investigator: James McCracken, MD University of California, Los Angeles
Principal Investigator: Bryan King, MD Seattle Children's Hospital
Principal Investigator: Christopher McDougle, MD Massachusetts General Hospital
Principal Investigator: James Dziura, MPH, PhD Yale University
  More Information

Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01238575     History of Changes
Other Study ID Numbers: R01MH083707, R01MH083707
Study First Received: October 29, 2010
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Yale University:
Asperger's Disorder
Pervasive Developmental Disorders
PDD
PDD-NOS
Autistic Disorder
Autism
Hyperactivity
Attention Deficit Hyperactivity Disorder
ADHD
Medication
Drug
Guanfacine
Intuniv
Placebo
Methylphenidate

Additional relevant MeSH terms:
Disease
Hyperkinesis
Developmental Disabilities
Child Development Disorders, Pervasive
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders
Methylphenidate
Guanfacine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on September 18, 2014