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Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder

NCT01238575 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2020-03-31

Study results available
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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).

Conditions

  • Pervasive Development Disorders

Interventions

OTHER

placebo

Administered for up to 8 weeks.

DRUG

extended-release guanfacine

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

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Seattle Children's Hospital

    collaborator OTHER

  • University of California, Los Angeles

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Lawrence Scahill, MSN, PhD · Emory University

  • James McCracken, MD · University of California, Los Angeles

  • Bryan King, MD · Seattle Children's Hospital

  • Christopher McDougle, MD · Massachusetts General Hospital

  • James Dziura, MPH, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01238575 on ClinicalTrials.gov