Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder

NCT01238575 | Completed Phase 4 Results DMC

• 2 other identifiers: 1001006172R01MH083707
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Pervasive Development Disorders

Keywords

Pervasive Developmental Disorders; PDD; PDD-NOS; Autistic Disorder; Autism; Asperger's Disorder; Hyperactivity; Attention Deficit Hyperactivity Disorder; ADHD; Medication; Drug; Guanfacine; Intuniv; Placebo; Methylphenidate

Outcome Measures

Primary Outcomes (1)

• Aberrant Behavior Checklist Hyperactivity Subscale

  The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48.

  Week 8

Secondary Outcomes (15)

• ADHD Rating Scale - Total

  Week 8

• Aberrant Behavior Checklist Irritability Subscale

  8 weeks

• Aberrant Behavior Checklist Social Withdrawal Subscale

  8 weeks

• Aberrant Behavior Checklist Sterotypy Subscale

  8 weeks

• Aberrant Behavior Checklist Inappropriate Speech Subscale

  8 weeks

Study Arms (2)

Extended-release guanfacine

EXPERIMENTAL

Drug: extended-release guanfacine

Inactive placebo

PLACEBO COMPARATOR

Other: placebo

Interventions

placebo OTHER

Administered for up to 8 weeks.

Inactive placebo

extended-release guanfacine DRUG

1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks

Also known as: Intuniv

Extended-release guanfacine

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Prior failed treatment with an adequate trial of guanfacine in the last 2 years
• Concurrent treatment with another psychoactive medication

Sponsors & Collaborators

• Yale University: lead
• Emory University: collaborator
• Massachusetts General Hospital: collaborator
• Seattle Children's Hospital: collaborator
• University of California, Los Angeles: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (5)

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Massachusetts General Hospital

Lexington, Massachusetts, 02142, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98101, United States

Location

Related Publications (2)

• 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. doi: 10.1089/cap.2006.16.589.

  PMID: 17069547 BACKGROUND

• Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

  PMID: 37811711 DERIVED

MeSH Terms

Conditions

Child Development Disorders, Pervasive; Autistic Disorder; Asperger Syndrome; Spasm; Attention Deficit Disorder with Hyperactivity

Interventions

Guanfacine

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Autism Spectrum Disorder; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Attention Deficit and Disruptive Behavior Disorders

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Results Point of Contact

• Title: Lawrence Scahill, MSN, PhD
• Organization: Emory University

lawrence.scahill@emory.edu

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 10, 2010
• Study Start: December 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 31, 2020
• Results First Posted: December 7, 2015

Record last verified: 2020-03

Locations

US (5)