Inuniv and Working Memory

This study is currently recruiting participants.

Verified December 2012 by Schweickert, Lori A., M.D.

Sponsor:

Collaborator:

Shire Development LLC

Information provided by (Responsible Party):

Lori A. Schweickert, MD, Schweickert, Lori A., M.D.

ClinicalTrials.gov Identifier:

NCT01177306

First received: July 29, 2010

Last updated: December 14, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 29, 2010

Last Updated Date

December 14, 2012

Start Date ^ICMJE

July 2010

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Central Nervous System-Vital Signs (CNS-VS) [ Time Frame: 6-8 weeks on stable dose of study drug ] [ Designated as safety issue: No ]

standardized computer administered battery

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01177306 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Wide Range Assessment of Memory and Learning(WRAML) [ Time Frame: 6-8 weeks on stable dose of study drug ] [ Designated as safety issue: No ]

psychologist administered battery assessing working memory

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Inuniv and Working Memory

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Attention Deficit Hyperactivity Disorder

Intervention ^ICMJE

Drug: extended release guanfacine

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

Study Arm (s)

Experimental: 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.

Intervention: Drug: extended release guanfacine

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

8 Years to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Lori A Schweickert, MD	919 677-0101 ext 533	schweickert@3cfs.com
Contact: Sharon A Leuenberger, PhD	919 677-0101	leuenberger@3cfs.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01177306

Other Study ID Numbers ^ICMJE

LAS-IST-001

Has Data Monitoring Committee

Yes

Responsible Party

Lori A. Schweickert, MD, Schweickert, Lori A., M.D.

Study Sponsor ^ICMJE

Lori A. Schweickert, MD

Collaborators ^ICMJE

Shire Development LLC

Investigators ^ICMJE

Principal Investigator:

Lori A Schweickert, MD

3C Family Services

Information Provided By

Schweickert, Lori A., M.D.

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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