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NCT05183919

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

Completed NA Last updated 28 February 2023
What this trial tests

NA trial testing Digital Treatment in Attention Deficit Hyperactivity Disorder in 223 participants. Completed in 13 January 2023.

Timeline
29 November 2021
Primary endpoint
13 January 2023
13 January 2023

Quick facts

Lead sponsorAkili Interactive Labs, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment223
Start date29 November 2021
Primary completion13 January 2023
Estimated completion13 January 2023
Sites14 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Akili Interactive Labs, Inc.

Who can join

18 and older, any sex, with Attention Deficit Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Digital therapeutics in the clinic.
    Phan P, Mitragotri S, Zhao Z. · · 2023 · cited 39× · PMID 37476062 · DOI 10.1002/btm2.10536
  2. Real-time cognitive performance metrics derived from a digital therapeutic for inattention predict ADHD-related clinical outcomes: Replication across three independent trials of AKL-T01.
    Stamatis CA, Heusser AC, Simon TJ, Ala'ilima T, et al · · 2024 · cited 4× · PMID 39128918 · DOI 10.1038/s41398-024-03045-0
  3. Two single arm trials of AKL-T01, a digital therapeutic for adolescents and adults with ADHD.
    Stamatis CA, Farlow DN, Mercaldi C, Suh M, et al · · 2024 · cited 3× · PMID 38898133 · DOI 10.1038/s44184-024-00075-w
  4. Secondary analyses of sex differences in attention improvements across three clinical trials of a digital therapeutic in children, adolescents, and adults with ADHD.
    Flannery JE, Hinshaw SP, Kollins SH, Stamatis CA. · · 2024 · cited 2× · PMID 38685016 · DOI 10.1186/s12889-024-18597-5
  5. ACNP 62nd Annual Meeting: Poster Abstracts P1 – P250
    · 2023

Verify or expand the search:

Other recruiting trials for Attention Deficit Hyperactivity Disorder

Currently open trials in the same condition.

Other Akili Interactive Labs, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05183919.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing