EndeavorOTC for Attention Deficit Disorder

Not currently recruiting at 1 trial location

Overseen By Minny Suh, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Akili Interactive Labs, Inc.

Disqualifiers: Photosensitive epilepsy, color blindness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 42

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital therapy called EndeavorOTC to assess its impact on attention and cognitive skills in university students. The goal is to determine if this digital tool can enhance focus and emotional health. Participants will use an app for 12 weeks, with one group starting immediately and another group waiting six weeks. It suits university students who own a smartphone or tablet and wish to improve their attention and cognitive functioning. As an unphased trial, this study provides a unique opportunity for students to potentially enhance their cognitive skills and emotional well-being through innovative digital therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this digital therapeutic is safe for university students?

Research shows that EndeavorOTC is a safe treatment for adults with ADHD. The FDA has approved this digital therapy for use without a prescription. In earlier studies, many participants experienced noticeable improvements in their ADHD symptoms. Specifically, 32.7% of participants saw their ADHD Rating Scale scores drop by at least 30%.

While EndeavorOTC is generally well-tolerated, it is not recommended for people with other psychiatric conditions in addition to ADHD. Thus, while the treatment is safe for many, those with more complex mental health issues should consult their healthcare providers. Overall, evidence supports that EndeavorOTC is a safe and effective way to improve attention and reduce ADHD symptoms in adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

EndeavorOTC is unique because it offers a non-pharmaceutical approach to managing Attention Deficit Disorder, utilizing a digital therapy platform instead of traditional medication like stimulants or non-stimulants. Unlike other treatments that often involve pills, EndeavorOTC delivers engaging video game-like experiences designed to target and improve cognitive functions directly related to attention. Researchers are excited about this treatment because it has the potential to provide a fun, side-effect-free option that can be easily integrated into daily life, making it a game-changer for those who prefer or require alternatives to medication.

What evidence suggests that EndeavorOTC is effective for Attention Deficit Disorder?

Research has shown that EndeavorOTC, a digital therapy tool, holds promise for improving attention deficit disorder symptoms. In earlier studies, 37% of users no longer showed signs of attention deficit, and 33% experienced significant improvements in their ADHD symptoms. Additionally, 83% of participants reported better focus after using EndeavorOTC for six weeks. Users noted increased productivity, with 78% feeling more productive and 73% experiencing a better quality of life. These results suggest that EndeavorOTC could effectively manage attention and thinking issues. Participants in this trial will receive either immediate or delayed access to EndeavorOTC to further evaluate its effectiveness. ^{1 4 6 7 8}

Who Is on the Research Team?

Caitlin Stamatis, PhD

Principal Investigator

Akili Interactive Labs, Inc.

Are You a Good Fit for This Trial?

This study is for university students who may have attention issues or want to improve their cognitive functioning. Participants should be interested in trying a digital therapeutic called EndeavorOTC®.

Inclusion Criteria

Owns a personal Android or iOS device to access AKL-T01 treatment

Provides informed consent to participate in this study

Exclusion Criteria

Has participated in the same study in previous semesters

I don't have epilepsy, color blindness, or physical issues that make using apps hard.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12-week access to EndeavorOTC, a digital therapeutic, to evaluate its impact on cognitive and emotional health

12 weeks

Baseline, Day 42, Day 84 assessments

Follow-up

Participants are monitored for changes in cognitive functioning, academic outcomes, social functioning, attention, and quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EndeavorOTC®

Trial Overview The trial is testing the effects of a digital therapy app, EndeavorOTC®, on executive and cognitive functions in college students. It aims to see if this app can help with focus, memory, and other brain skills.

How Is the Trial Designed?

Group I: Group 2 Experimental Treatment 1 Intervention

Participants receive 12-week access to EndeavorOTC 6-weeks after Group 1.

Group II: Group 1 Experimental Treatment 1 Intervention

Participants receive immediate 12-week access to EndeavorOTC.

Who Is Running the Clinical Trial?

Akili Interactive Labs, Inc.

Lead Sponsor

Trials

17

Recruited

2,100+

Landmark College

Collaborator

Trials

1

Recruited

70+

Villa Maria College

Collaborator

Trials

1

Recruited

70+

Published Research Related to This Trial

Game-based digital therapeutics (DTx), like EndeavorRx®, significantly improved inattention and hyperactivity/impulsivity in children with ADHD compared to control groups, based on assessments from parents and teachers.

However, traditional medication was found to be more effective than game-based DTx in reducing inattention and hyperactivity/impulsivity, indicating that while DTx offers a beneficial alternative, it may not replace conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of game-based digital therapeutics on attention deficit hyperactivity disorder in children and adolescents as assessed by parents or teachers: a systematic review and meta-analysis. Oh, S., Choi, J., Han, DH., et al.[2023]

Citations

1. endeavorotc.com endeavorotc.com/evidence/

Evidence 37% no longer exhibited an attention deficit · 33% had clinically meaningful improvements in ADHD symptoms · 61% reported clinically meaningful improvements in ...

2. endeavorotc.com endeavorotc.com/evidence/stars-adhd-adolescent/

STARS-ADHD Adolescent Following treatment, participants in the study showed significant improvement on both the inattention subscale and total score of the ADHD-RS (p<0.0001 for both) ...

3. endeavorotc.com endeavorotc.com/

EndeavorOTC | A Digital Treatment for Adult ADHD 60% were better able to complete projects on time ; 78% reported increased productivity ; 54% were better able to keep track of important items such as their keys ...

4. dtxalliance.org dtxalliance.org/products/endeavorotc/

EndeavorOTC After 6-weeks of EndeavorOTC use, 83% of participants saw clinical improvements in their ability to focus after 6 weeks, 73% reported better quality of life ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11317482/

Real-time cognitive performance metrics derived from a digital ... We aimed to derive a real-time measure of attention from AKL-T01 gameplay data and validate it against clinical outcomes. Trials of AKL-T01 ...

6. endeavorotc.com endeavorotc.com/evidence/stars-adhd-adult-study/

STARS-ADHD Adult Study A prespecified responder analysis also showed that 32.7% of all participants in the study demonstrated at least a 30% reduction in total scores on the ADHD-RS.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K233496.pdf

June 14, 2024 Akili Interactive Labs, Inc. Bhupinder Singh ... EndeavorOTC is not for persons who have a comorbid psychiatric condition in addition to. ADHD. When using this device it is recommended that ...

8. endeavorrx.com endeavorrx.com/

EndeavorRx® - ADHD Video Game Treatment for Kids | FDA ... 68% of parents reported improvement in ADHD-related impairments after two months of treatment. 2. 73% of children reported an improvement in their attention. 1.