Inuniv and Working Memory

NCT ID: NCT01177306

Last Updated: 2014-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-05-31

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.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

extended release guanfacine

Intervention Type DRUG

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

Interventions

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extended release guanfacine

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

Intervention Type DRUG

Other Intervention Names

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Intuniv Serial Number 306 IND 63,551

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shire

INDUSTRY

Sponsor Role collaborator

Lori A. Schweickert, MD

INDIV

Sponsor Role lead

Responsible Party

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Lori A. Schweickert, MD

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lori A Schweickert, MD

Role: PRINCIPAL_INVESTIGATOR

3-C Family Services

Locations

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3C Family Services

Cary, North Carolina, United States

Site Status

Countries

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United States

References

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Sallee FR, Lyne A, Wigal T, McGough JJ. Long-term safety and efficacy of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2009 Jun;19(3):215-26. doi: 10.1089/cap.2008.0080.

Reference Type RESULT
PMID: 19519256 (View on PubMed)

Wang M, Ramos BP, Paspalas CD, Shu Y, Simen A, Duque A, Vijayraghavan S, Brennan A, Dudley A, Nou E, Mazer JA, McCormick DA, Arnsten AF. Alpha2A-adrenoceptors strengthen working memory networks by inhibiting cAMP-HCN channel signaling in prefrontal cortex. Cell. 2007 Apr 20;129(2):397-410. doi: 10.1016/j.cell.2007.03.015.

Reference Type RESULT
PMID: 17448997 (View on PubMed)

Other Identifiers

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LAS-IST-001

Identifier Type: -

Identifier Source: org_study_id

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