Inuniv and Working Memory

Study Overview
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Brief Summary
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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.

Official Title
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Phase 4 Study of the Effect of Extended Release Guanfacine on Working Memory in Children With ADHD

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: extended release guanfacine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended Release Guanfacine<br>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<br>* 1-4 mg daily. Dose determined by response of ADHD symptoms to drug and by body mass limitations<br>* Other names: IND 63,551;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, working memory