Status:
COMPLETED
Inuniv and Working Memory
Lead Sponsor:
Lori A. Schweickert, MD
Collaborating Sponsors:
Shire
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
8-12 years
Phase:
PHASE4
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 b...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01177306
Start Date
July 1 2010
End Date
May 1 2014
Last Update
July 28 2014
Active Locations (1)
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1
3C Family Services
Cary, North Carolina, United States, 27513