Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
18 participants
INTERVENTIONAL
2010-07-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
extended release guanfacine
1-4 mg daily. Dose determined by response of ADHD symptoms to drug and by body mass limitations
Interventions
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extended release guanfacine
1-4 mg daily. Dose determined by response of ADHD symptoms to drug and by body mass limitations
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
8 Years
12 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Lori A. Schweickert, MD
INDIV
Responsible Party
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Lori A. Schweickert, MD
MD
Principal Investigators
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Lori A Schweickert, MD
Role: PRINCIPAL_INVESTIGATOR
3-C Family Services
Locations
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3C Family Services
Cary, North Carolina, United States
Countries
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References
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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.
Other Identifiers
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LAS-IST-001
Identifier Type: -
Identifier Source: org_study_id
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