Software Treatment for Actively Reducing Severity of ADHD as Adjunctive Treatment to Stimulant

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title: Software Treatment for Actively Reducing Severity of ADHD as Adjunctive Treatment to Stimulant (STARS-ADHD Adjunctive)

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the effects of combining AKL-T01 (with AKL-X01 symptom tracking) as adjunctive treatment to stimulant medication, and to understand the effects of AKL-T01 treatment (with AKL-X01 symptom tracking) in participants not recently on medication.

Clinical Trial Description

The study aims to enroll (203) participants, with a confirmed diagnoses of ADHD, at approximately 15 sites and will be divided between 2 cohorts; 130 participants will be enrolled in Cohort 1, and 73 participants will be enrolled in Cohort 2.

Cohort 1 will have been stable (adherence to a prescribed medication schedule) on a stimulant medication, but are inadequately managed by the stimulant (in the opinion of the investigator). The stimulant is managed by their own physician for at least 30 days before baseline. This is the Stimulant cohort.

Cohort 2 will have been stable without any stimulant medication for at least 30 days before the baseline. This is the Non-Stimulant cohort.

For both cohorts, at least 7 and up to 30 days before baseline, participants' caretakers will begin using AKL-X01 (Fengo) to track their participants' symptoms and behaviors.

During Treatment Phase 1 (Days 1 through 28) participants in Cohort 1 (Stimulant) will continue to receive their current stimulant plus the addition of AKL-T01. Participants in Cohort 2 (Non-Stimulant) will just receive AKL-T01. For both cohorts, during this time the caretakers will monitor their child's symptoms daily with AKL-X01.

During the 1-Month Break (Days 29 through 56) between AKL-T01 treatment phases, participants in Cohort 1 will continue to receive their current stimulant. In both cohorts, AKL-T01 will be suspended during this time. For both cohorts, during this time caretakers will continue to monitor their child's symptoms daily with AKL-X01.

During Treatment Phase 2 (Days 57 through 84), participants in Cohort 1 (stimulant) will continue to receive their current stimulant plus the addition of AKL-T01. Participants in Cohort 2 will just receive AKL-T01. For both cohorts, during this time the caretakers will monitor their child's symptoms daily with AKL-X01.

AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time.

AKL-T01: Videogame-like digital therapy ;

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

• NCT number: NCT03649074
• Study type: Interventional
• Source: Akili Interactive Labs, Inc.
• Status: Completed
• Phase: N/A
• Start date: December 28, 2018
• Completion date: September 23, 2019