Software Treatment for Actively Reducing Severity of ADHD in Adults (STARS ADHD Adult)

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title: A Single Arm, Adaptive Design, Pivotal Trial to Assess the Efficacy of AKL-T01, a Novel Digital Intervention Designed to Improve Attention, in Adults Diagnosed With Attention Deficit Hyperactive Disorder

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the effects of the videogame-like digital therapy on attentional functioning and symptoms in Adults diagnosed with ADHD.

Clinical Trial Description

This study is a multi-center, unblinded/non-controlled adaptive design study to evaluate objective attention functioning and ADHD symptoms and impairments in adults with a diagnosis of ADHD (combined or inattentive subtype), stably on or off ADHD medication, after 6 weeks of AKL-T01 treatment. A maximum of 325 total participants from 12-30 sites will be enrolled. During the Screening/baseline, participants will undergo screening to evaluate eligibility for the study. Eligible participants will continue onto baseline procedures in the same visit. Treatment phase (Day 2-42) will involve using the digital therapy at home for each participant. Compliance with treatment/use requirements will be monitored remotely during this phase. An In-Clinic assessment will be completed on Day 42 to assess key outcomes. ;

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

• NCT number: NCT05183919
• Study type: Interventional
• Source: Akili Interactive Labs, Inc.
• Status: Completed
• Phase: N/A
• Start date: November 29, 2021
• Completion date: January 13, 2023