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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01146002
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : April 2, 2014
Information provided by (Responsible Party):
Neurology Group of Bergen County, P.A.

Brief Summary:
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 or disease Intervention/treatment Phase
Attention-deficit/Hyperactivity Disorder Drug: Guanfacine (sustained release) Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Language-based Learning Skills and ADHD: Impact of Treatment With Sustained-release Guanfacine
Study Start Date : June 2010
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. one-tailed t-test [ Time Frame: 7 weeks ]
    Improvement in Woodcock Johnson III score when taking sustained release guanfacine, compared to score on the same test prior to treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

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.
ClinicalTrials.gov Identifier: NCT01146002     History of Changes
Other Study ID Numbers: Guanfacine learning study
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: April 2014

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
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs