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Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder

This study is currently recruiting participants.
Verified March 2013 by Yale University
Sponsor:
Collaborators:
Massachusetts General Hospital
Seattle Children's Hospital
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01238575
First received: October 29, 2010
Last updated: March 18, 2013
Last verified: March 2013
History of Changes

October 29, 2010
March 18, 2013
December 2011
March 2014   (final data collection date for primary outcome measure)
Aberrant Behavior Checklist Hyperactivity Subscale [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01238575 on ClinicalTrials.gov Archive Site
ADHD Rating Scale [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder
Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder

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).

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pervasive Development Disorders
  • Drug: methylphenidate
    5 mg tablets; flexible dosing up to 37.5 mg/day for up to 4 weeks in addition to extended release guanfacine.
  • Other: placebo
    Administered for up to 16 weeks.
  • Drug: extended-release guanfacine
    1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
    Other Name: Intuniv
  • Experimental: Extended-release guanfacine
    Intervention: Drug: extended-release guanfacine
  • Placebo Comparator: Inactive placebo
    Intervention: Other: placebo
  • Experimental: Methylphenidate add-on
    Interventions:
    • Drug: methylphenidate
    • Drug: extended-release guanfacine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
112
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
5 Years to 14 Years
No
Contact: Lawrence Scahill, MSN, PhD lawrence.scahill@emory.edu
United States
 
NCT01238575
R01MH083707, R01MH083707
Yes
Yale University
Yale University
  • Massachusetts General Hospital
  • Seattle Children's Hospital
  • University of California, Los Angeles
  • National Institute of Mental Health (NIMH)
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
Yale University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP