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OpenTrials
Completed

NCT Number: NCT01177306

Inuniv and Working Memory

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

3C Family Services

Cary, North Carolina, 27513, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

extended release guanfacine

Drug

1-4 mg daily. Dose determined by response of ADHD symptoms to drug and by body mass limitations

Other names: Intuniv, Serial Number 306, IND 63,551

Primary outcomes

  1. Central Nervous System-Vital Signs (CNS-VS)

    Time frame: 6-8 weeks on stable dose of study drug

    standardized computer administered battery

Secondary outcomes

  1. Wide Range Assessment of Memory and Learning(WRAML)

    Time frame: 6-8 weeks on stable dose of study drug

    psychologist administered battery assessing working memory

Sponsors and collaborators

Lead sponsor

Lori A. Schweickert, MD

Indiv

Collaborators

  • Shire

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Aug 9, 2010
Registry last updated
Jul 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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