Status:
COMPLETED
Software Treatment for Actively Reducing Severity of ADHD in Adults (STARS ADHD Adult)
Lead Sponsor:
Akili Interactive Labs, Inc.
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2023
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT05183919
Start Date
November 29 2021
End Date
January 13 2023
Last Update
February 28 2023
Active Locations (14)
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1
Melmed Center
Scottsdale, Arizona, United States, 85254
2
CNS Clinical Research Trials
Garden Grove, California, United States, 92845
3
Innovative Clinical Research, Inc.
Lauderhill, Florida, United States, 33319
4
Accel Research Sites
Maitland, Florida, United States, 32751