- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01238575
Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90024
- University of California, Los Angeles
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Connecticut
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New Haven, Connecticut, United States, 06519
- Yale University
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Georgia
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Atlanta, Georgia, United States, 30329
- Emory University
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Massachusetts
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Lexington, Massachusetts, United States, 02142
- Massachusetts General Hospital
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Washington
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Seattle, Washington, United States, 98101
- Seattle Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Inactive placebo
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Administered for up to 8 weeks.
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Experimental: Extended-release guanfacine
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1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aberrant Behavior Checklist Hyperactivity Subscale
Time Frame: Week 8
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ADHD Rating Scale - Total
Time Frame: Week 8
|
The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change.
The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician.
The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items).
If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale.
Results from this rating scale alone should not be used to make a diagnosis.
The total score can range from 0 to 54, with a higher score indicating greater severity.
|
Week 8
|
Aberrant Behavior Checklist Irritability Subscale
Time Frame: 8 weeks
|
The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation.
It is a 58 item checklist which takes about 10 - 15 minutes to complete.
There are five subscales: a) Irritability and Agitation b) Lethargy and Social Withdrawal c) Stereotypic Behavior d) Hyperactivity and Noncompliance and e) Inappropriate Speech.
The higher the number of items (score), the greater the amount of symptoms.
Scores can range from 0 to 45.
|
8 weeks
|
Aberrant Behavior Checklist Social Withdrawal Subscale
Time Frame: 8 weeks
|
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.
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.
This subscale's scores can range from 0 to 48.
|
8 weeks
|
Aberrant Behavior Checklist Sterotypy Subscale
Time Frame: 8 weeks
|
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.
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.
This subscale's scores can range from 0 to 21.
|
8 weeks
|
Aberrant Behavior Checklist Inappropriate Speech Subscale
Time Frame: 8 weeks
|
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.
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.
This subscale's scores can range from 0 to 12.
|
8 weeks
|
ADHD Rating Scale - Inattention Subscale
Time Frame: 8 weeks
|
The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change.
The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician.
The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items).
If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale.
Results from this rating scale alone should not be used to make a diagnosis.
This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.
|
8 weeks
|
ADHD Rating Scale - Hyperactivity Subscale
Time Frame: 8 weeks
|
The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change.
The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician.
The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items).
If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale.
Results from this rating scale alone should not be used to make a diagnosis.
This subscale can range from 0 to 27 for scoring,with a higher score indicating greater severity.
|
8 weeks
|
Aberrant Behavior Checklist Hyperactivity Subscale
Time Frame: Baseline
|
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. |
Baseline
|
Aberrant Behavior Checklist Irritability Subscale
Time Frame: Baseline
|
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.
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.
Scores for this subscale can range from 0 to 45.
|
Baseline
|
Aberrant Behavior Checklist Social Withdrawal Subscale
Time Frame: Baseline
|
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.
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.
This subscale's scores can range from 0 to 48.
|
Baseline
|
Aberrant Behavior Checklist Sterotypy Subscale
Time Frame: Baseline
|
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.
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.
This subscale's scores can range from 0 to 21.
|
Baseline
|
Aberrant Behavior Checklist Inappropriate Speech Subscale
Time Frame: Baseline
|
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.
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.
This subscale's scores can range from 0 to 12.
|
Baseline
|
ADHD Rating Scale - Inattention Subscale
Time Frame: Baseline
|
The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change.
The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician.
The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items).
If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale.
Results from this rating scale alone should not be used to make a diagnosis.
This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.
|
Baseline
|
ADHD Rating Scale - Hyperactivity Subscale
Time Frame: Baseline
|
The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change.
The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician.
The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items).
If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale.
Results from this rating scale alone should not be used to make a diagnosis.
This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.
|
Baseline
|
ADHD Rating Scale - Total
Time Frame: Baseline
|
The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change.
The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician.
The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items).
If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale.
Results from this rating scale alone should not be used to make a diagnosis.
The total score can range from 0 to 54, with a higher score indicating greater severity.
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: James McCracken, MD, University of California, Los Angeles
- Principal Investigator: Lawrence Scahill, MSN, PhD, Emory University
- Principal Investigator: Christopher McDougle, MD, Massachusetts General Hospital
- Principal Investigator: James Dziura, MPH, PhD, Yale University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Neurodevelopmental Disorders
- Disease
- Autism Spectrum Disorder
- Hyperkinesis
- Child Development Disorders, Pervasive
- Developmental Disabilities
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Guanfacine
Other Study ID Numbers
- 1001006172
- R01MH083707 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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