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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: extended release guanfacine

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Cary, North Carolina, United States, 27513
      • 3C Family Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Nervous System-Vital Signs (CNS-VS)	standardized computer administered battery	6-8 weeks on stable dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wide Range Assessment of Memory and Learning(WRAML)	psychologist administered battery assessing working memory	6-8 weeks on stable dose of study drug

Collaborators and Investigators

• Sponsor: Lori A. Schweickert, MD
• Collaborators: Shire
• Investigators: Principal Investigator: Lori A Schweickert, MD, 3-C Family Services

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: July 29, 2010
• First Submitted That Met QC Criteria: August 5, 2010
• First Posted (Estimate): August 9, 2010

Study Record Updates

• Last Update Posted (Estimate): July 28, 2014
• Last Update Submitted That Met QC Criteria: July 25, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: ADHD, working memory
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Guanfacine
• Other Study ID Numbers: LAS-IST-001