Inuniv and Working Memory

This study has been completed.
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: July 25, 2014
Last verified: July 2014

July 29, 2010
July 25, 2014
July 2010
December 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01177306 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Inuniv and Working Memory
Phase 4 Study of the Effect of Extended Release Guanfacine on Working Memory in Children With ADHD

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Attention Deficit Hyperactivity Disorder
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
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.
Intervention: Drug: extended release guanfacine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
May 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
8 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01177306
LAS-IST-001
Yes
Lori A. Schweickert, MD, Schweickert, Lori A., M.D.
Lori A. Schweickert, MD
Shire
Principal Investigator: Lori A Schweickert, MD 3C Family Services
Schweickert, Lori A., M.D.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP