Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder

NCT ID: NCT01238575

Last Updated: 2020-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-03-31

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).

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.

The study protocol was formally revised with the Yale University IRB in May 2013 to address an early close to enrollment due to a reduction in funding. The original anticipated enrollment numbers of 112 subjects was reduced to 60 subjects. The study statistician was consulted prior to enrollment closure to address any issues related to statistical power and the adjustments made to the final statiscal analysis plan.

Conditions

Pervasive Development Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Extended-release guanfacine

Group Type: EXPERIMENTAL

extended-release guanfacine

Intervention Type: DRUG

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

Inactive placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Administered for up to 8 weeks.

Interventions

placebo

Administered for up to 8 weeks.

Intervention Type: OTHER

extended-release guanfacine

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

Intervention Type: DRUG

Other Intervention Names

Intuniv

Eligibility 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Seattle Children's Hospital

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrence Scahill, MSN, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

James McCracken, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Bryan King, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Christopher McDougle, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

James Dziura, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

University of California, Los Angeles

Los Angeles, California, United States

Yale University

New Haven, Connecticut, United States

Emory University

Atlanta, Georgia, United States

Massachusetts General Hospital

Lexington, Massachusetts, United States

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17069547 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37811711 (View on PubMed)

Other Identifiers

R01MH083707

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1001006172

Identifier Type: -

Identifier Source: org_study_id