Title
Inuniv and Working Memory
Phase 4 Study of the Effect of Extended Release Guanfacine on Working Memory in Children With ADHD
Phase
Phase 4Lead Sponsor
Lori A. Schweickert, MDStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Attention Deficit Hyperactivity DisorderIntervention/Treatment
guanfacine ...Study Participants
18Minimum 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.
1-4 mg daily. Dose determined by response of ADHD symptoms to drug and by body mass limitations
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.
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
