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Inuniv and Working Memory

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
extended release guanfacine
Sponsored by
Lori A. Schweickert, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, working memory

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 3C Family Services

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Extended Release Guanfacine

Arm Description

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.

Outcomes

Primary Outcome Measures

Central Nervous System-Vital Signs (CNS-VS)
standardized computer administered battery

Secondary Outcome Measures

Wide Range Assessment of Memory and Learning(WRAML)
psychologist administered battery assessing working memory

Full Information

First Posted
July 29, 2010
Last Updated
July 25, 2014
Sponsor
Lori A. Schweickert, MD
Collaborators
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01177306
Brief Title
Inuniv and Working Memory
Official Title
Phase 4 Study of the Effect of Extended Release Guanfacine on Working Memory in Children With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lori A. Schweickert, MD
Collaborators
Shire

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, working memory

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extended Release Guanfacine
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
extended release guanfacine
Other Intervention Name(s)
Intuniv, Serial Number 306, IND 63,551
Intervention Description
1-4 mg daily. Dose determined by response of ADHD symptoms to drug and by body mass limitations
Primary Outcome Measure Information:
Title
Central Nervous System-Vital Signs (CNS-VS)
Description
standardized computer administered battery
Time Frame
6-8 weeks on stable dose of study drug
Secondary Outcome Measure Information:
Title
Wide Range Assessment of Memory and Learning(WRAML)
Description
psychologist administered battery assessing working memory
Time Frame
6-8 weeks on stable dose of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori A Schweickert, MD
Organizational Affiliation
3-C Family Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
3C Family Services
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27513
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19519256
Citation
Sallee FR, Lyne A, Wigal T, McGough JJ. Long-term safety and efficacy of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2009 Jun;19(3):215-26. doi: 10.1089/cap.2008.0080.
Results Reference
result
PubMed Identifier
17448997
Citation
Wang M, Ramos BP, Paspalas CD, Shu Y, Simen A, Duque A, Vijayraghavan S, Brennan A, Dudley A, Nou E, Mazer JA, McCormick DA, Arnsten AF. Alpha2A-adrenoceptors strengthen working memory networks by inhibiting cAMP-HCN channel signaling in prefrontal cortex. Cell. 2007 Apr 20;129(2):397-410. doi: 10.1016/j.cell.2007.03.015.
Results Reference
result

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Inuniv and Working Memory

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