Cognitive ADHD Videogame Exploratory Study

Completed · Not applicable

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

A study in ADHD and neuro-typical children to assess EVO game play over 29 days.

Key facts

Study ID

NCT01943539

Run by

Akili Interactive Labs, Inc.

People needed

84

Starts

2013-09-01

Expected to finish

2015-05-01

Last updated by the study team

2017-12-13

Who can join

Age: 8 and older, up to 12. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 8 to 12 at the time of parental informed consent.
• Confirmed ADHD diagnosis at clinic per MINI-Kid (ADHD Cohort)
• Baseline ADHD-RS-IV score >= 24 (ADHD Cohort), obtained at clinic
• Baseline ADHD-RS-IV score <=13 (Neuro-typical Cohort), obtained at clinic
• Consistently off ADHD drug for 1 week. Drugs include: Pre specified, oral psychostimulants (ADDERALL XR® [mixed salts of a single-entity amphetamine product], VYVANSE® [lisdexamfetamine dimesylate], CONCERTA® [methylphenidate HCl], FOCALIN XR® [dexmethylphenidate HCl], RITALIN LA® [methylphenidate HCl extended-release], METADATE CD® [methylphenidate HCl, USP], or FDA-approved generic equivalents )for 1 month (Other than ADHD drud
• Consistently off Psychotropic drug for 1 month (Other than ADHD drug noted above)
• Ability to follow written and verbal instructions (English)
• Girls or Boys (Gender-matched - 30% girls minimum)
• Functioning at an age-appropriate level intellectually.
• Ability to comply with all the testing and requirements.

You may not qualify if…

• Current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, or other symptomatic manifestations that in the opinion of the Investigator that may confound study data/assessments (per MINI-Kid).
• Within the last 4 weeks, subject has entered or exited behavioral therapy. The subject should inform the Investigator if they intend to change their behavioral therapy during the 4 weeks of the study.
• Subject 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 (per C-SSRS).
• History of failure to respond to an adequate trial of 2 treatments for ADHD (consisting of an appropriate dose and adequate duration of therapy and failure in efficacy in the opinion of the Investigator).
• Motor condition that prevents game playing
• Recent history (within the past 6 months) of suspected substance abuse or dependence.
• History of seizures (exclusive of febrile seizures), a tic disorder, significant tics, or a current diagnosis of Tourette's Disorder.
• Taken part in a clinical trial within 30 days prior to screening.
• Diagnosis of color blindness
• Regular use of psychoactive drugs that in the opinion of the Investigator may confound study data/assessments.
• Any other medical condition that in the opinion of the Investigator may confound study data/assessments.

Where it is running

• Florida Clinical Research Center, LLC — Bradenton, Florida, United States
• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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