NCT01177306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 9, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 28, 2014

Status Verified

July 1, 2014

Enrollment Period

3.4 years

First QC Date

July 29, 2010

Last Update Submit

July 25, 2014

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD, working memory

Outcome Measures

Primary Outcomes (1)

  • Central Nervous System-Vital Signs (CNS-VS)

    standardized computer administered battery

    6-8 weeks on stable dose of study drug

Secondary Outcomes (1)

  • Wide Range Assessment of Memory and Learning(WRAML)

    6-8 weeks on stable dose of study drug

Study Arms (1)

Extended Release Guanfacine

EXPERIMENTAL

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.

Drug: extended release guanfacine

Interventions

extended release guanfacineDRUG

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

Also known as: Intuniv, Serial Number 306, IND 63,551
Extended Release Guanfacine

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • Outpatient status
  • \. Age 8-12 (inclusive) at baseline
  • \. Males or Pre-menarchal females
  • \. English-speaking parent and subject
  • \. If on stimulant medication, has demonstrated sub-optimal response to treatment ad is willing to be washed out (discontinued) from stimulant
  • \. Intellectual capacity to provide assent, as deemed by the Principal Investigator
  • \. No known cardiac history, including bradycardia, heart block, syncope or tachycardia
  • \. No known history of hypotension or hypotension at baseline
  • \. Willing to provide informed consent/ assent per IRB protocol

You may not qualify if:

  • 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
  • Outpatient status
  • \. Age 8-12 (inclusive) at baseline
  • \. Males or Pre-menarchal females
  • \. English-speaking parent and subject
  • \. If on stimulant medication, has demonstrated sub-optimal response to treatment ad is willing to be washed out (discontinued) from stimulant
  • \. Intellectual capacity to provide assent, as deemed by the Principal Investigator
  • \. No known cardiac history, including bradycardia, heart block, syncope or or tachycardia
  • \. No known history of hypotension or hypotension at baseline
  • \. Willing to provide informed consent/ assent per IRB protocol 11. No history of hepatic or renal impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

3C Family Services

Cary, North Carolina, 27513, United States

Location

Related Publications (2)

  • 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.

    PMID: 19519256RESULT

  • 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.

    PMID: 17448997RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Guanfacine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Lori A Schweickert, MD

    3-C Family Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 29, 2010

First Posted

August 9, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2013

Study Completion

May 1, 2014

Last Updated

July 28, 2014

Record last verified: 2014-07

Locations

US(1)