Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder
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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 |
- Aberrant Behavior Checklist Hyperactivity Subscale [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Lawrence Scahill, MSN, PhD | lawrence.scahill@emory.edu |
| 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 | |
| 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: | March 18, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Yale University:
|
Pervasive Developmental Disorders PDD PDD-NOS Autistic Disorder Autism Asperger's Disorder Hyperactivity Attention Deficit Hyperactivity Disorder |
ADHD Medication Drug Guanfacine Intuniv Placebo Methylphenidate |
Additional relevant MeSH terms:
|
Developmental Disabilities Hyperkinesis Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Methylphenidate Guanfacine Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Antihypertensive Agents Cardiovascular Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents |
ClinicalTrials.gov processed this record on May 16, 2013