Software Treatment for Actively Reducing Severity of ADHD in Adults (STARS ADHD Adult)
NCT ID: NCT05183919
Last Updated: 2023-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
223 participants
INTERVENTIONAL
2021-11-29
2023-01-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AKL-T01
Digital treatment
Digital Treatment
AKL-T01 multitasking digital treatment. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task.
Interventions
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Digital Treatment
AKL-T01 multitasking digital treatment. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task.
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Stably on or off ADHD medications for ≥4 weeks prior to study enrollment and throughout the primary 6-week study
4. Stably on or off psychoactive medications for ≥4 weeks prior to study enrollment and throughout the 6-week study
5. Baseline visit score on the ADHD-RS-IV of ≥ 24
6. Baseline visit score on the TOVA-ACS score ≤ -1.8
7. Estimated IQ score ≥80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II)
8. Access to and self-report of ability to connect wireless devices to a functional wireless network
9. Ability to follow written and verbal instructions (English) as assessed by the PI and/or study coordinator
10. Able to comply with all testing and study requirements
11. Completion of informed consent form
Exclusion Criteria
2. Suicidality assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS)
3. Motor condition (e.g., physical deformity of the hands/arms) that prevents game playing as reported by the participant or observed by the Investigator.
4. History of moderate or severe substance use disorder within the last 12 months prior to informed consent
5. History of seizures (excluding febrile seizures), significant tics, or a current diagnosis of Tourette's Disorder.
6. Known sensitivity to playing video games, such as photo-sensitive epilepsy, light-headedness, dizziness, nausea, or motion sickness.
7. Color blindness as detected by Ishihara Color Blindness Test
8. Positive urine drug screen
9. 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
10. Any other medical condition that in the opinion of the Investigator may confound study data/assessments.
11. Participation in a clinical trial within 3 months prior to screening.
12. Previous exposure to Akili products within the 6 months prior to study enrollment
13. 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.
14. Planned initiation of, or significant changes in frequency, of non-pharmacological behavioral therapy during the primary study
15. 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
18 Years
ALL
No
Sponsors
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Akili Interactive Labs, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Flannery JE, Hinshaw SP, Kollins SH, Stamatis CA. Secondary analyses of sex differences in attention improvements across three clinical trials of a digital therapeutic in children, adolescents, and adults with ADHD. BMC Public Health. 2024 Apr 29;24(1):1195. doi: 10.1186/s12889-024-18597-5.
Other Identifiers
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Akili-057
Identifier Type: -
Identifier Source: org_study_id
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