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

Completed · Not applicable

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

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.

Key facts

Study ID

NCT05183919

Run by

Akili Interactive Labs, Inc.

People needed

223

Starts

2021-11-29

Expected to finish

2023-01-13

Last updated by the study team

2023-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 18 years and older
• Diagnosis of ADHD combined or inattentive type, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as confirmed by Mini International Neuropsychiatric Interview (MINI) for Attention - Deficit / Hyperactivity Disorders Studies (Adult) 7.0.2
• Stably on or off ADHD medications for ≥4 weeks prior to study enrollment and throughout the primary 6-week study
• Stably on or off psychoactive medications for ≥4 weeks prior to study enrollment and throughout the 6-week study
• Baseline visit score on the ADHD-RS-IV of ≥ 24
• Baseline visit score on the TOVA-ACS score ≤ -1.8
• Estimated IQ score ≥80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II)
• Access to and self-report of ability to connect wireless devices to a functional wireless network
• Ability to follow written and verbal instructions (English) as assessed by the PI and/or study coordinator
• Able to comply with all testing and study requirements
• Completion of informed consent form

You may not qualify if…

• Current controlled or uncontrolled, comorbid psychiatric diagnosis with significant symptoms that in the opinion of the Investigator may confound study data/assessments.
• Suicidality assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS)
• Motor condition (e.g., physical deformity of the hands/arms) that prevents game playing as reported by the participant or observed by the Investigator.
• History of moderate or severe substance use disorder within the last 12 months prior to informed consent
• History of seizures (excluding febrile seizures), significant tics, or a current diagnosis of Tourette's Disorder.
• Known sensitivity to playing video games, such as photo-sensitive epilepsy, light-headedness, dizziness, nausea, or motion sickness.
• Color blindness as detected by Ishihara Color Blindness Test
• Positive urine drug screen
• Current or recent (3 months prior to screening) history of heavy smoking defined as the equivalent of greater than or equal to a pack of cigarettes a day
• Any other medical condition that in the opinion of the Investigator may confound study data/assessments.
• Participation in a clinical trial within 3 months prior to screening.
• Previous exposure to Akili products within the 6 months prior to study enrollment
• Plans to initiate new concomitant medications during the primary study, except for common over the counter (OTC) (e.g., ibuprofen, acetaminophen) and prescription medications (e.g., antibiotics) for minor transient ailments.
• Planned initiation of, or significant changes in frequency, of non-pharmacological behavioral therapy during the primary study
• Planned initiation of, or significant changes in frequency of, non-pharmacological trainings with the aim to improve cognition by means of game or app-based cognitive trainings or neurofeedback, during the primary study

Where it is running

• Melmed Center — Scottsdale, Arizona, United States
• CNS Clinical Research Trials — Garden Grove, California, United States
• Innovative Clinical Research, Inc. — Lauderhill, Florida, United States
• Accel Research Sites — Maitland, Florida, United States
• Behavioral Clinical Research, Inc. — Miami Lakes, Florida, United States
• Midwest Research Group — Saint Charles, Missouri, United States
• Alivation Research — Lincoln, Nebraska, United States
• Center for Psychiatry and Behavioral Medicine, Inc. — Las Vegas, Nevada, United States
• Hassman Research Institute — Berlin, New Jersey, United States
• Albuquerque Neuroscience, Inc. — Albuquerque, New Mexico, United States
• MindPath Care Centers — Raleigh, North Carolina, United States
• IPS Research — Oklahoma City, Oklahoma, United States
• FutureSearch Trials — Dallas, Texas, United States
• Southeast Houston Research, Inc. — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.