Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder

Yale University

Status and phase: Completed; Phase 4

Conditions: Pervasive Development Disorders

Treatments: Drug: extended-release guanfacine; Other: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01238575

1001006172

R01MH083707 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 5 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups, including a placebo group

Extended-release guanfacine

Experimental group

Treatment:

Drug: extended-release guanfacine

Inactive placebo

Placebo Comparator group

Treatment:

Other: placebo