Language-based Learning Skills and Attention Deficit Hyperactivity Disorder (ADHD): Impact of Treatment With Sustained-release Guanfacine

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Neurology Group of Bergen County, P.A.
ClinicalTrials.gov Identifier:
NCT01146002
First received: June 15, 2010
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

This study is investigating the effect of sustained-release guanfacine (Intuniv) on language-based learning skills in children age 6-12 who are diagnosed with attention deficit hyperactivity disorder (ADHD).


Condition Intervention Phase
Attention-deficit/Hyperactivity Disorder
Drug: Guanfacine (sustained release)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Language-based Learning Skills and ADHD: Impact of Treatment With Sustained-release Guanfacine

Resource links provided by NLM:


Further study details as provided by Neurology Group of Bergen County, P.A.:

Primary Outcome Measures:
  • one-tailed t-test [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    Improvement in Woodcock Johnson III score when taking sustained release guanfacine, compared to score on the same test prior to treatment.


Enrollment: 30
Study Start Date: June 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Guanfacine treated.
Single arm - all patients treated with study drug. Comparison is against pre-treatment performance.
Drug: Guanfacine (sustained release)
Treated with study drug once screening and initial testing is completed (see protocol above)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Diagnosis of ADHD-inattentive or combined type.

Exclusion Criteria:

  • Intelligence (IQ) below 85 as determined by formal testing.
  • Identified or suspected genetic syndromes.
  • Autism or other pervasive developmental disorders.
  • Psychiatric disorders other than ADHD and oppositional defiant disorder.
  • Heart, liver or renal disease.
  • Cancer.
  • Epilepsy or non-febrile seizure history.
  • Cardiac arrhythmia, bradycardia, or syncope.
  • Any other condition considered to be potentially exacerbated or endangered by treatment with an alpha-2 agonist drug.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146002

Locations
United States, New Jersey
Neurology Group of Bergen County
Ridgewood, New Jersey, United States, 07450
Sponsors and Collaborators
Neurology Group of Bergen County, P.A.
Shire
  More Information

No publications provided

Responsible Party: Neurology Group of Bergen County, P.A.
ClinicalTrials.gov Identifier: NCT01146002     History of Changes
Other Study ID Numbers: Guanfacine learning study
Study First Received: June 15, 2010
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Neurology Group of Bergen County, P.A.:
Attention-deficit/hyperactivity disorder, primarily inattentive or combined type.

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Guanfacine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014