Cortical Excitability: Phenotype and Biomarker in Attention-deficit, Hyperactivity Disorder (ADHD) Therapy

NCT01330693 | Unknown Phase 3 DMC

• 1 other identifier: 1R01MH081854-01A2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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. 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".

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD; Atomoxetine; Biomarker

Outcome Measures

Primary Outcomes (3)

• Efficacy outcome as change from baseline in ADHDRS total score

  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

  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.

  2 hours (at baseline visit)

Study Arms (2)

Atomoxetine

ACTIVE COMPARATOR

Atomoxetine is FDA-approved for the treatment of ADHD symptoms in children

Drug: Atomoxetine

Placebo

PLACEBO COMPARATOR

Sugar pill

Drug: Sugar Pill

Interventions

Atomoxetine DRUG

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.

Also known as: Strattera

Atomoxetine

Sugar Pill DRUG

In-active sugar pill randomly assigned at baseline visit

Placebo

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride; Sugars

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Carbohydrates

Study Officials

• Floyd R Sallee, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: April 7, 2011
• Study Start: September 1, 2009
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

US (2)