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

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


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

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 identifier: NCT01146002

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.
  More Information

1. Shaywitz S, Beecher J, Shaywitz G. Issues in the definition and classification of attention deficit disorder. Topics in language disorders . 1994;14:1-25.. 2. Pastura G, Mattos P, Prufer A. Academic Performance in ADHD When Controlled for Comorbid Learning Disorders, Family Income, and Parental Education in Brazil. J J Att Dis. 2009;12:469-473 3. Barbaresi W, Katusic W, Slavica K et al. Modifier of long-term school outcomes for children with attention-deficit/hyperactivity disorder. Does treatment with stimulant medication make a difference? Results from a population based study.; J Devel Behav Pediatrics. 2007;28(4):274-287. 4. Forness S, Kavale K (2002): Impact of ADHD on School Systems. In: Jensen P and Cooper J, Attention Deficit Hyperactivity Disorder. Kingston NJ: Civic Research Inst.; 24-3 - 24-7. 5. Pliszka S, Carlson C, Wanson J (1999). Learning Disorders. In: ADHD with Comorbid Disorders. New York: Guilford Press; 188-201. 6. Gianarris W, Golden C, Greene L. The Conners' parent rating scales: a critical review of the literature. Clin Psychol Rev. 2001;21:1061-1093. 7. Scheffler RM, Brown TT, Fulton BD et al Positive association between attention deficit/hyperactivity disorder medication use and academic achievement during elementary school. Pediatrics 2009;123(5):1273-1279 8. Biederman J, Boellner S, Childress A et al. Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. Biol Psychiatry 2007;62:970-976. 9. Pelham WE, Manos MJ, Ezzell CE, et al. A dose-ranging study of a methylphenidate transdermal system in children with ADHD. J Am Acad Child Adolesc Psychiatry 2005;44:522-9. 10. Mayes S, Calhous S. Frequency of reading, math, and writing disabilities in children with clinical disorders. Learning and Individual Differences. 2006;16:145-157.

Responsible Party: Neurology Group of Bergen County, P.A. 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
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
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 processed this record on November 24, 2015