Attention Deficit Hyperactivity DisorderPhase 4NCT01177306
Inuniv and Working Memory
A Phase 4 study testing extended release guanfacine in people with Attention Deficit Hyperactivity Disorder, run by Lori A. Schweickert, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- extended release guanfacine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- • 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of the Effect of Extended Release Guanfacine on Working Memory in Children With ADHD
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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- extended release guanfacine
- Keywords
- ADHD, working memory
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extended release guanfacineDrug
Also called Intuniv, Serial Number 306, IND 63,551
1-4 mg daily. Dose determined by response of ADHD symptoms to drug and by body mass limitations
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: extended release guanfacine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Nervous System-Vital Signs (CNS-VS)
standardized computer administered battery
Measured: 6-8 weeks on stable dose of study drug
Secondary outcomes (1)
Wide Range Assessment of Memory and Learning(WRAML)
psychologist administered battery assessing working memory
Measured: 6-8 weeks on stable dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lori A. Schweickert, MD
- Collaborators
- Shire
- Responsible party
- Sponsor-investigator, Lori A. Schweickert, MD, Schweickert, Lori A., M.D.
- Investigators
- Lori A Schweickert, MD, Principal investigator, 3-C Family Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177306
- Sponsor's protocol ID
- LAS-IST-001
- Status last verified
- Jul 2014
- First submitted
- 29 Jul 2010
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19519256Wang 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.
PubMed 17448997
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of the Effect of Extended Release Guanfacine on Working Memory in Children With ADHD
- ClinicalTrials.gov ID
- NCT01177306
- Acronym / sponsor ID
- LAS-IST-001
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, working memory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Lori A. Schweickert, MD
- Collaborators
- Shire
- Study start
- Jul 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extended Release Guanfacine | Experimental | Drug: extended release guanfacinepre 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- • 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extended release guanfacineAlso: Intuniv, Serial Number 306, IND 63,5511-4 mg daily. Dose determined by response of ADHD symptoms to drug and by body mass limitations | Drug | Extended Release Guanfacine |
Primary outcome
Central Nervous System-Vital Signs (CNS-VS)
Time frame: 6-8 weeks on stable dose of study drug
standardized computer administered battery
1 secondary outcome
Wide Range Assessment of Memory and Learning(WRAML)
Time frame: 6-8 weeks on stable dose of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
- Results publication: PubMed 19519256Sallee 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.
- Results publication: PubMed 17448997Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori A Schweickert, MD principal investigator
3-C Family Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing extended release guanfacine in people with Attention Deficit Hyperactivity Disorder, run by Lori A. Schweickert, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Nervous System-Vital Signs (CNS-VS) (time frame: 6-8 weeks on stable dose of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01177306, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2014; AzTrials last refreshed its copy on 30 Oct 2026.