- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01330693
Cortical Excitability: Phenotype and Biomarker in Attention-deficit, Hyperactivity Disorder (ADHD) Therapy
August 17, 2015 updated by: Floyd Sallee, University of Cincinnati
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".
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital
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Cincinnati, Ohio, United States, 45219
- University of Cincinnati
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Sugar pill
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In-active sugar pill randomly assigned at baseline visit
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Active Comparator: Atomoxetine
Atomoxetine is FDA-approved for the treatment of ADHD symptoms in children
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy outcome as change from baseline in ADHDRS total score
Time Frame: At 4 weeks
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At 4 weeks
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SICI as a marker of ADHD Behaviors
Time Frame: Baseline visit
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To evaluate pTMS-evoked Short Interval Cortical Inhibition (SICI) as a marker of the hyperactive-impulsive dimension in Attention Deficit Hyperactivity Disorder
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Baseline visit
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Cognitive Correlates of SICI Change
Time Frame: 2 hours (at baseline visit)
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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.
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2 hours (at baseline visit)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Floyd R Sallee, MD, University of Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Anticipated)
November 1, 2015
Study Completion (Anticipated)
November 1, 2015
Study Registration Dates
First Submitted
April 5, 2011
First Submitted That Met QC Criteria
April 6, 2011
First Posted (Estimate)
April 7, 2011
Study Record Updates
Last Update Posted (Estimate)
August 19, 2015
Last Update Submitted That Met QC Criteria
August 17, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Adrenergic Uptake Inhibitors
- Atomoxetine Hydrochloride
Other Study ID Numbers
- 1R01MH081854-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Atomoxetine
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