Inuniv and Working Memory
This study is currently recruiting participants.
Verified December 2012 by Schweickert, Lori A., M.D.
Sponsor:
Lori A. Schweickert, MD
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: extended release guanfacine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Phase 4 Study of the Effect of Extended Release Guanfacine on Working Memory in Children With ADHD |
Resource links provided by NLM:
Further study details as provided by Schweickert, Lori A., M.D.:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 24 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: extended release guanfacine
1-4 mg daily. Dose determined by response of ADHD symptoms to drug and by body mass limitations
Other Names:
|
Eligibility| Ages Eligible for Study: | 8 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177306
Contacts
| Contact: Lori A Schweickert, MD | 919 677-0101 ext 533 | schweickert@3cfs.com |
| Contact: Sharon A Leuenberger, PhD | 919 677-0101 | leuenberger@3cfs.com |
Locations
| United States, North Carolina | |
| 3C Family Services | Recruiting |
| Cary, North Carolina, United States, 27513 | |
| Contact: Lori A Schweickert, MD 919-677-0101 ext 533 schweickert@3cfs.com | |
| Contact: Leigh Blaylock, MD 919 677-0101 blaylock@3cfs.com | |
| Principal Investigator: Lori A Schweickert, MD | |
Sponsors and Collaborators
Lori A. Schweickert, MD
Shire Development LLC
Investigators
| Principal Investigator: | Lori A Schweickert, MD | 3C Family Services |
More Information
Publications:
| Responsible Party: | Lori A. Schweickert, MD, MD, Schweickert, Lori A., M.D. |
| ClinicalTrials.gov Identifier: | NCT01177306 History of Changes |
| Other Study ID Numbers: | LAS-IST-001 |
| Study First Received: | July 29, 2010 |
| Last Updated: | December 14, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Schweickert, Lori A., M.D.:
|
ADHD, working memory |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Guanfacine Antihypertensive Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013