Inuniv and Working Memory

This study is currently recruiting participants.
Verified December 2012 by Schweickert, Lori A., M.D.
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Lori A. Schweickert, MD, Schweickert, Lori A., M.D.
ClinicalTrials.gov Identifier:
NCT01177306
First received: July 29, 2010
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

Minimum 24 subjects aged 8-12 with a diagnosis of ADHD will be prescribed extended release guanfacine (Intuniv) to assess impact, if any, on working memory. Pre and post testing using a standardized battery of tests for effect on symptoms of ADHD and working memory will be administered and assessed.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: extended release guanfacine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Phase 4 Study of the Effect of Extended Release Guanfacine on Working Memory in Children With ADHD

Resource links provided by NLM:


Further study details as provided by Schweickert, Lori A., M.D.:

Primary Outcome Measures:
  • Central Nervous System-Vital Signs (CNS-VS) [ Time Frame: 6-8 weeks on stable dose of study drug ] [ Designated as safety issue: No ]
    standardized computer administered battery


Secondary Outcome Measures:
  • Wide Range Assessment of Memory and Learning(WRAML) [ Time Frame: 6-8 weeks on stable dose of study drug ] [ Designated as safety issue: No ]
    psychologist administered battery assessing working memory


Estimated Enrollment: 24
Study Start Date: July 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extended Release Guanfacine
pre and post testing of working memory in subjects whose ADHD has responded to extended release guanfacine. Subjects will be tested before starting study drug and after 6-8 weeks on a stable dose of the study drug.
Drug: extended release guanfacine
1-4 mg daily. Dose determined by response of ADHD symptoms to drug and by body mass limitations
Other Names:
  • Intuniv
  • Serial Number 306
  • IND 63,551

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1.Meet DSM-IV criteria for ADHD, combined, inattentive, or hyperactive/impulsive subtype, as evidenced by minimum score of 24 on the ADHD-RS-IV at baseline

  • 2 Outpatient status
  • 3. Age 8-12 (inclusive) at baseline
  • 4. Males or Pre-menarchal females
  • 5. English-speaking parent and subject
  • 6. If on stimulant medication, has demonstrated sub-optimal response to treatment ad is willing to be washed out (discontinued) from stimulant
  • 7. Intellectual capacity to provide assent, as deemed by the Principal Investigator
  • 8. No known cardiac history, including bradycardia, heart block, syncope or tachycardia
  • 9. No known history of hypotension or hypotension at baseline
  • 10. Willing to provide informed consent/ assent per IRB protocol

Exclusion Criteria:

  • • 1.Meet DSM-IV criteria for ADHD, combined, inattentive, or hyperactive/impulsive subtype, as evidenced by minimum score of 24 on the ADHD-RS-IV at baseline

    • 2 Outpatient status
    • 3. Age 8-12 (inclusive) at baseline
    • 4. Males or Pre-menarchal females
    • 5. English-speaking parent and subject
    • 6. If on stimulant medication, has demonstrated sub-optimal response to treatment ad is willing to be washed out (discontinued) from stimulant
    • 7. Intellectual capacity to provide assent, as deemed by the Principal Investigator
    • 8. No known cardiac history, including bradycardia, heart block, syncope or or tachycardia
    • 9. No known history of hypotension or hypotension at baseline
    • 10. Willing to provide informed consent/ assent per IRB protocol 11. No history of hepatic or renal impairment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177306

Contacts
Contact: Lori A Schweickert, MD 919 677-0101 ext 533 schweickert@3cfs.com
Contact: Sharon A Leuenberger, PhD 919 677-0101 leuenberger@3cfs.com

Locations
United States, North Carolina
3C Family Services Recruiting
Cary, North Carolina, United States, 27513
Contact: Lori A Schweickert, MD    919-677-0101 ext 533    schweickert@3cfs.com   
Contact: Leigh Blaylock, MD    919 677-0101    blaylock@3cfs.com   
Principal Investigator: Lori A Schweickert, MD         
Sponsors and Collaborators
Lori A. Schweickert, MD
Shire
Investigators
Principal Investigator: Lori A Schweickert, MD 3C Family Services
  More Information

Publications:
Responsible Party: Lori A. Schweickert, MD, MD, Schweickert, Lori A., M.D.
ClinicalTrials.gov Identifier: NCT01177306     History of Changes
Other Study ID Numbers: LAS-IST-001
Study First Received: July 29, 2010
Last Updated: December 14, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Schweickert, Lori A., M.D.:
ADHD, working memory

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

ClinicalTrials.gov processed this record on April 21, 2014