NCT01146002

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

April 2, 2014

Status Verified

April 1, 2014

Enrollment Period

2.7 years

First QC Date

June 15, 2010

Last Update Submit

April 1, 2014

Conditions

Attention-deficit/Hyperactivity Disorder

Keywords

Attention-deficit/hyperactivity disorder, primarily inattentive or combined type.

Outcome Measures

Primary Outcomes (1)

  • one-tailed t-test

    Improvement in Woodcock Johnson III score when taking sustained release guanfacine, compared to score on the same test prior to treatment.

    7 weeks

Study Arms (1)

Guanfacine treated.

OTHER

Single arm - all patients treated with study drug. Comparison is against pre-treatment performance.

Drug: Guanfacine (sustained release)

Interventions

Guanfacine (sustained release)DRUG

Treated with study drug once screening and initial testing is completed (see protocol above)

Guanfacine treated.

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurology Group of Bergen County

Ridgewood, New Jersey, 07450, United States

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Guanfacine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2010

First Posted

June 17, 2010

Study Start

June 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

April 2, 2014

Record last verified: 2014-04

Locations

US(1)