Phase 4
Completed N=62
Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder
Pervasive Development Disorders
Source: ClinicalTrials.gov NCT01238575 ↗
Enrolled (actual)
62
Serious AEs
1.6%
Results posted
Dec 2015
Primary outcomePrimary: Aberrant Behavior Checklist Hyperactivity Subscale — 19.3; 29.7 units on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aberrant Behavior Checklist Hyperactivity Subscale |
34.4; 34.25 | — |
| SECONDARY ADHD Rating Scale - Total |
39.53; 39.91 | — |
| SECONDARY Aberrant Behavior Checklist Irritability Subscale |
20.3; 18.06 | — |
| SECONDARY Aberrant Behavior Checklist Social Withdrawal Subscale |
13.6; 12.06 | — |
| SECONDARY Aberrant Behavior Checklist Sterotypy Subscale |
8.53; 9.31 | — |
| SECONDARY Aberrant Behavior Checklist Inappropriate Speech Subscale |
6.33; 6.84 | — |
| SECONDARY ADHD Rating Scale - Inattention Subscale |
20.53; 20.41 | — |
| SECONDARY ADHD Rating Scale - Hyperactivity Subscale |
19.00; 19.5 | — |
| SECONDARY Aberrant Behavior Checklist Hyperactivity Subscale |
34.4; 34.25 | — |
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
Data sourced from ClinicalTrials.gov (NCT01238575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.