Inuniv and Working Memory

Lori A. Schweickert, MD

Status and phase: Completed; Phase 4

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: extended release guanfacine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01177306

LAS-IST-001

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Extended Release Guanfacine

Experimental group

Description:

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.

Treatment:

Drug: extended release guanfacine