Clinical trial NCT01177306: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD, working memory
Lead sponsor: Schweickert, Lori A., M.D.
Sponsor class: INDIV
Collaborators: name: Shire
First posted: 2010-08-09
Enrollment: 18
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Central Nervous System-Vital Signs (CNS-VS)
timeFrame: 6-8 weeks on stable dose of study drug
Secondary outcomes:
measure: Wide Range Assessment of Memory and Learning(WRAML)
timeFrame: 6-8 weeks on stable dose of study drug
Other outcomes:
Locations:
city: Cary
country: United States
facility: 3C Family Services
state: North Carolina
Study officials:
affiliation: 3-C Family Services
name: Lori A Schweickert, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.