Inuniv and Working Memory

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01177306

Enrollment

Registered

2010-08-09

Start date

2010-07-31

Completion date

2014-05-31

Last updated

2014-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD, working memory

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.

Interventions

DRUGextended release guanfacine

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to 12 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026