Attention Deficit Disorder With HyperactivityPhase 3NCT01330693
Cortical Excitability: Phenotype and Biomarker in Attention-deficit, Hyperactivity Disorder (ADHD) Therapy
A Phase 3 study testing Atomoxetine and Sugar Pill in people with Attention Deficit Disorder With Hyperactivity, run by University of Cincinnati at 2 sites in United States.
Trial summary
The purpose of this study is to find out if children with attention-deficit, hyperactivity disorder (ADHD) have a difference in how their brain cells "fire" or react. The investigators also want to find if brain cell "firing" can tell us how severe of symptoms a child has from ADHD. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Atomoxetine and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Nov 2015
- Phase
- Phase 3
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed informed consent and assent
- Meets DSM-IV criteria for ADHD, combined or inattentive subtype, based on K-SADS interview
- Scores at least 1.5 SD higher than age and gender mean on ADHD RS, keyed to ADHD subtype (i.e., combined score for the combined subtype, inattentive subscale only for inattentive subtype, etc.)
- Age: 7 - 12 years at study entry
- Findings on physical exam, laboratory studies and ECG are judged to be normal for age and gender, as determined by study physician at study entry
- There is not a co-existing medical condition for which TMS or ATX is contraindicated (for example pheochromocytoma).
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- Pulse and blood pressure within 95% of age and gender mean
- Full scale IQ >75 (i.e., excluding mental retardation and the lower level of the borderline range)
- Able to complete study instruments and swallow capsules
- Willing to commit to the entire visit schedule for the study
- No previous treatment with Atomoxetine
- Must either be naive to ADHD study medication or not doing well on the current ADHD medication.
Who cannot join
- Has one of the following exclusionary diagnoses: autism/ pervasive developmental disorder, mental retardation, schizophrenia, a psychotic disorder, bipolar disorder, severe depressive or conduct disorder
- Has a comorbid disorder that is otherwise allowable, but which requires a treatment that is not being offered in the study, and should be the primary focus of treatment, in the opinion of the PI
- Has a medical or neurologic disorder that would preclude taking the ATX, or which would potentially confound the assessment of ADHD and/or TMS outcomes, in the opinion of the PI (for example pheochromocytoma, or for specific purposes of this study uncontrolled seizure disorder or organic brain syndrome).
- Taking a systemic medication which might interfere with the metabolism or efficacy assessment of ATX in this study
- History of allergic reactions to multiple medications
- History of alcohol or drug abuse in the past 3 months Has been in a medication treatment study in the past 30 days
- Females of childbearing age who are sexually active, do not use acceptable birth control (double barrier method), or are not abstinent. Abstinence is defined as no sexual activity for at least 3 months before the start of the study and the intention to abstain from sexual activity during the study period). Double barrier methods allowed include: condoms or diaphragms combined with spermicide use, intrauterine devices (IUD), and oral, transdermal, injectable or implantable hormonal medications (Ortho-Evra, Norplant, Depo-Provera, and similar prescription products) for at least one month before entering the study and continuing its use throughout the study. Birth control pills alone are not acceptable forms of birth control for this study.
- Has any prior neurological condition that might increase the risk of an adverse event with TMS. For the purpose of this study we are excluding children with a current or prior history of epilepsy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Cincinnati
Cincinnati, Ohio, 45219
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
About this study
Official title: Cortical Excitability: Phenotype and Biomarker in ADHD Therapy
The purpose of this study is to find out if children with attention-deficit, hyperactivity disorder (ADHD) have a difference in how their brain cells "fire" or react. The investigators also want to find if brain cell "firing" can tell us how severe of symptoms a child has from ADHD. Finally, the investigators want to see if giving an ADHD medication called atomoxetine can make the ADHD symptoms in a child better and if the improvement shows a change in brain "firing".
Read the detailed description
This study will evaluate Short Interval Intracortical Inhibition (SICI) measured by pTMS as a marker of the hyperactive-impulsive dimension in 120 ADHD 7-12 years, medication-free children. This study will characterize the effects of a single dose of atomoxetine compared to placebo on cognitive correlates of SICI change. Participants will be randomized 2:1 to either atomoxetine or placebo. The study will also characterize the effects of four weeks of atomoxetine treatment on cortical inhibition and will correlate SICI change with clinical outcomes.
- Being tested
- Atomoxetine, Sugar Pill
- Keywords
- ADHD, Atomoxetine, Biomarker
- 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.
AtomoxetineDrug
Also called Strattera
Atomoxetine is FDA-approved for the treatment of ADHD symptoms in children. Single dose of 0.5 mg/kg at baseline visit. Then dose adjusted in an open-label design afterwards.
Sugar PillDrug
In-active sugar pill randomly assigned at baseline visit
| Study group | Role | What they receive |
|---|---|---|
| Atomoxetine | Active comparator | Atomoxetine is FDA-approved for the treatment of ADHD symptoms in children Receives: Drug: Atomoxetine |
| Placebo | Placebo comparator | Sugar pill Receives: Drug: Sugar Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy outcome as change from baseline in ADHDRS total score
Measured: At 4 weeks
SICI as a marker of ADHD Behaviors
To evaluate pTMS-evoked Short Interval Cortical Inhibition (SICI) as a marker of the hyperactive-impulsive dimension in Attention Deficit Hyperactivity Disorder
Measured: Baseline visit
Cognitive Correlates of SICI Change
To determine cognitive correlates of SICI change, the study will first measure SICI at at rest and concurrently during the Stop-task. This process will then be repeated 2 hours after a single dose (0.5 mg/kg) of atomoxetine (ATX) or placebo.
Measured: 2 hours (at baseline visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startSep 2009
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Floyd Sallee, University of Cincinnati
- Investigators
- Floyd R Sallee, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330693
- Sponsor's protocol ID
- 1R01MH081854-01A2
- Other IDs
- 1R01MH081854-01A2
- Status last verified
- Aug 2015
- First submitted
- 5 Apr 2011
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Excitability: Phenotype and Biomarker in ADHD Therapy
- ClinicalTrials.gov ID
- NCT01330693
- Acronym / sponsor ID
- 1R01MH081854-01A2
- Keywords
- ADHD, Atomoxetine, Biomarker
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2009
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 7 Apr 2011 (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.
The purpose of this study is to find out if children with attention-deficit, hyperactivity disorder (ADHD) have a difference in how their brain cells "fire" or react. The investigators also want to find if brain cell "firing" can tell us how severe of symptoms a child has from ADHD. Finally, the investigators want to see if giving an ADHD medication called atomoxetine can make the ADHD symptoms in a child better and if the improvement shows a change in brain "firing".
Detailed description
This study will evaluate Short Interval Intracortical Inhibition (SICI) measured by pTMS as a marker of the hyperactive-impulsive dimension in 120 ADHD 7-12 years, medication-free children. This study will characterize the effects of a single dose of atomoxetine compared to placebo on cognitive correlates of SICI change. Participants will be randomized 2:1 to either atomoxetine or placebo. The study will also characterize the effects of four weeks of atomoxetine treatment on cortical inhibition and will correlate SICI change with clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atomoxetine | Active comparator | Drug: AtomoxetineAtomoxetine is FDA-approved for the treatment of ADHD symptoms in children |
| Placebo | Placebo comparator | Drug: Sugar PillSugar pill |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Signed informed consent and assent
- Meets DSM-IV criteria for ADHD, combined or inattentive subtype, based on K-SADS interview
- Scores at least 1.5 SD higher than age and gender mean on ADHD RS, keyed to ADHD subtype (i.e., combined score for the combined subtype, inattentive subscale only for inattentive subtype, etc.)
- Age: 7 - 12 years at study entry
- Findings on physical exam, laboratory studies and ECG are judged to be normal for age and gender, as determined by study physician at study entry
Key exclusion criteria (8 listed)
- Has one of the following exclusionary diagnoses: autism/ pervasive developmental disorder, mental retardation, schizophrenia, a psychotic disorder, bipolar disorder, severe depressive or conduct disorder
- Has a comorbid disorder that is otherwise allowable, but which requires a treatment that is not being offered in the study, and should be the primary focus of treatment, in the opinion of the PI
- Has a medical or neurologic disorder that would preclude taking the ATX, or which would potentially confound the assessment of ADHD and/or TMS outcomes, in the opinion of the PI (for example pheochromocytoma, or for specific purposes of this study uncontrolled seizure disorder or organic brain syndrome).
- Taking a systemic medication which might interfere with the metabolism or efficacy assessment of ATX in this study
- History of allergic reactions to multiple medications
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 |
|---|---|---|
| AtomoxetineAlso: StratteraAtomoxetine is FDA-approved for the treatment of ADHD symptoms in children. Single dose of 0.5 mg/kg at baseline visit. Then dose adjusted in an open-label design afterwards. | Drug | Atomoxetine |
| Sugar PillIn-active sugar pill randomly assigned at baseline visit | Drug | Placebo |
Primary outcome
Efficacy outcome as change from baseline in ADHDRS total score
Time frame: At 4 weeks
SICI as a marker of ADHD Behaviors
Time frame: Baseline visit
To evaluate pTMS-evoked Short Interval Cortical Inhibition (SICI) as a marker of the hyperactive-impulsive dimension in Attention Deficit Hyperactivity Disorder
Cognitive Correlates of SICI Change
Time frame: 2 hours (at baseline visit)
To determine cognitive correlates of SICI change, the study will first measure SICI at at rest and concurrently during the Stop-task. This process will then be repeated 2 hours after a single dose (0.5 mg/kg) of atomoxetine (ATX) or placebo.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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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.
Floyd R Sallee, MD principal investigator
University of Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atomoxetine and Sugar Pill in people with Attention Deficit Disorder With Hyperactivity, run by University of Cincinnati at 2 sites 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 12 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Efficacy outcome as change from baseline in ADHDRS total score (time frame: At 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2015.