Software Treatment for Actively Reducing Severity of ADHD - Follow Up



Status:Completed
Conditions:Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:8 - 12
Updated:2/14/2019
Start Date:August 2016
End Date:February 2018

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An Exploratory Study to Assess the Sustained Effects of Digital Therapy in Pediatric Subjects 8 to 12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)

This is an exploratory study to assess potential maintenance of clinical benefit (cognition
and symptoms) following 4 weeks of at-home digital therapy in ADHD children.

The study will be a blinded (investigators and outcome assessors), randomized (from parent
study Akili-001R), parallel group, follow-up study of the sustained effects of 4-weeks of
treatment with either AKL-T01 (EVO Multi) game-based digital therapy or AKL-T09 (EVO Words)
game-based digital therapy.

The trial will consist of 4 visits: Screening (to be conducted at the same time as the
end-of-study visit for the parent study Akili-001R), FU-Day 28 visit (conducted in clinic),
and FU-Day 56 and FU-Day 84 visits (conducted remotely via electronically captured parent
reported outcomes).

Inclusion Criteria:

- Completed Akili Study Akili-001R including all clinical assessments at DAY28 per the
study protocol

- Ability to comply with all the testing and requirements per this protocol

Exclusion Criteria:

- Participant is currently considered a suicide risk in the opinion of the Investigator,
has previously made a suicide attempt, or has a prior history of, or is currently
demonstrating active suicidal ideation or self-injurious behavior as measured by
C-SSRS at screening

- Participant has demonstrated clinically significant deterioration in functioning as
assessed by PI and other study staff that would contraindicate continued participation
in the follow-up study
We found this trial at
14
sites
Raleigh, North Carolina 27606
Principal Investigator: Sandeep Vaishnavi, MD, PhD
Phone: 919-763-7064
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Jeff Epstein, Ph.D.
Phone: 513-803-8913
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Scottt H Kollins, PhD
Phone: 919-681-0014
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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8043 Cooper Creek Boulevard Suite 107
Bradenton, Florida 34201
(941) 747-7900
Principal Investigator: Andrew Cutler
Phone: 941-747-7900
Florida Clinical Research Center, LLC Led by Andrew J. Cutler, M.D., Florida Clinical Research Center,...
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Bradenton, Florida
Principal Investigator: Andrew Cutler
Phone: 941-747-7900
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Durham, North Carolina 27705
Principal Investigator: Naomi Davis
Phone: 919-681-0013
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Las Vegas, Nevada 89128
Principal Investigator: Ann Childress, MD
Phone: 702-838-0742
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Las Vegas, NV
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Maitland, Florida 32751
Principal Investigator: Andrea Marraffino
Phone: 407-644-1165
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Maitland, FL
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Marshfield, Massachusetts 02050
Principal Investigator: Mary Ann McDonnell, Ph.D., RNCS
Phone: 774-275-4013
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Newport Beach, California 92660
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Sacramento, California 95817
Principal Investigator: Julie Schweitzer, Ph.D
Phone: 916-703-0294
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4801 Weldon Spring Parkway
Saint Charles, Missouri 63304
Principal Investigator: Greg Mattingly, MD
Phone: 636-946-8032
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Saint Charles, MO
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Scottsdale, Arizona 85254
Principal Investigator: Raun Melmed, MD
Phone: 480-443-0050
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Seattle, Washington 98115
Principal Investigator: Mark Stein, PhD
Phone: 206-884-1488
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Seattle, WA
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