Inuniv and Working Memory

Phase 4

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: extended release guanfacine

• Registration Number: NCT01177306
• Lead Sponsor: Lori A. Schweickert, MD

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 battery of tests for effect on symptoms of ADHD and working memory will be administered and assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-29
• Study First Submitted QC: 2010-08-05
• Study First Posted: 2010-08-09
• Primary Completion: 2013-12
• Study Completion: 2014-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-25
• Last Update Posted: 2014-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Extended Release Guanfacine	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.

Primary Outcome Measures

Name	Time	Method
Central Nervous System-Vital Signs (CNS-VS)	6-8 weeks on stable dose of study drug	standardized computer administered battery

Secondary Outcome Measures

Name	Time	Method
Wide Range Assessment of Memory and Learning(WRAML)	6-8 weeks on stable dose of study drug	psychologist administered battery assessing working memory

Trial Locations

Locations (1)

3C Family Services; 🇺🇸 Cary, North Carolina, United States