What side effects are associated with this type of intervention?

Common treatments for ADHD include stimulant medications like methylphenidate and amphetamines, as well as non-stimulant medications such as guanfacine. Stimulant medications can cause side effects such as insomnia, decreased appetite, weight loss, increased heart rate, and potential for substance abuse. Non-stimulant medications like guanfacine may cause drowsiness, fatigue, and low blood pressure. Game-based digital therapies, which are emerging as a treatment option, generally have fewer physical side effects but may lead to eye strain, headaches, or increased screen time-related issues. These therapies aim to improve attention and reduce hyperactivity/impulsivity through interactive game mechanics.

What other types of research exist?

Promising novel alternatives to game-based digital therapy for ADHD patients include: 1) Virtual Reality Serious Videogames, which have shown efficacy in improving attention and reducing hyperactivity/impulsivity in clinically drug-stable patients. 2) Online Chess Augmentation, which has also demonstrated effectiveness in similar patient populations. Both alternatives offer interactive and engaging methods to manage ADHD symptoms.

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Gameplay Therapy for Attention Deficit Hyperactivity Disorder (ADHD) (A-GAMES Trial)

Q: What prior FDA approvals exist?

The FDA has approved Akili Interactive's EndeavorRx as a game-based digital therapy for children with ADHD. This treatment engages patients through interactive game mechanics to improve attention and reduce hyperactivity/impulsivity. Additionally, traditional pharmacological treatments for ADHD include stimulant medications such as methylphenidate and amphetamines, which are commonly used to manage symptoms.

N/A

Recruiting

Led By Greg Mattingly, MD

Research Sponsored by Lumos Labs, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 22-55 years (Cohort I) or 18-21 years (Cohort II)

Current, stable use of an FDA approved pharmacological treatment for ADHD for at least 4 weeks prior to screening, but ADHD condition inadequately managed by that medication

Must not have

Any use of psychoactive drugs (other than ADHD medication) that in the opinion of the Investigator may confound study data/assessments

Unstable/uncontrolled, comorbid psychiatric diagnosis, based on clinical interviewing, with significant current active symptoms including but not limited to posttraumatic stress disorder, schizophrenia spectrum and other psychotic disorders, bipolar disorder, autism spectrum disorder, severe obsessive-compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, or other symptomatic manifestations that in the opinion of the Investigator may confound study data/assessments

Timeline

Screening 1 day

Treatment 13 weeks

Follow Up 1 day

Awards & highlights

Summary

This trial tests a digital game-based therapy to treat adults with ADHD. Results will show if it's safe and effective.

Who is the study for?

Adults aged 18-55 with ADHD, who can follow English instructions and have stable internet access for at-home digital therapy. Participants must be on steady ADHD medication but still experience symptoms. Excluded are those with recent substance abuse, high depression scores, or a history of seizures among other criteria.Check my eligibility

What is being tested?

The trial is testing an at-home game-based digital therapy to see if it helps adults manage their ADHD symptoms better. It's designed for those whose current medications aren't fully effective.See study design

What are the potential side effects?

Potential side effects may include discomforts related to video game use such as headaches, dizziness, or nausea. The study excludes individuals known to be sensitive to playing video games.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You are within the age range of 22-55 years (for Cohort I) or 18-21 years (for Cohort II).

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You have been using a certified medication to address your ADHD for the past 4 weeks and it has not sufficiently regulated your condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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You cannot take any psychoactive drugs (except for ADHD medication) that could affect the accuracy of the study's data and assessments, as determined by the researcher.

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You have a mental health condition that is not under control and may interfere with the study, such as severe depression, anxiety, PTSD, schizophrenia, bipolar disorder, or other serious mental health disorders.

Timeline

Screening ~ 1 day0 visits

Treatment ~ 13 weeks1 visit

Follow Up ~ 1 day0 visits

Screening ~ 1 day

Treatment ~ 13 weeks

Follow Up ~1 day

This trial's timeline: 1 day for screening, 13 weeks for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) Inattentive Symptoms subscale

Secondary outcome measures

Adult ADHD Self-Report Scale (ASRS) Inattentive Symptoms Subscale

Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) ADHD Symptoms Total subscale

Sheehan Disability Scale (SDS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: ADHD TherapyExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ADHD Therapy

2022

N/A

~560

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ADHD include stimulant medications (e.g., methylphenidate and amphetamines), non-stimulant medications (e.g., atomoxetine), and behavioral therapies (e.g., cognitive-behavioral therapy). Stimulant medications work by increasing the levels of dopamine and norepinephrine in the brain, which helps improve attention and reduce impulsivity and hyperactivity. Non-stimulant medications, like atomoxetine, selectively inhibit the reuptake of norepinephrine, enhancing attention and impulse control. Behavioral therapies focus on teaching coping strategies and skills to manage symptoms. Game-based digital therapies, such as the one being studied, engage patients through interactive game mechanics to improve attention and reduce hyperactivity/impulsivity, offering a novel, non-pharmacological approach that can be particularly appealing to patients seeking alternative or adjunctive treatments.

Serious Video Games: Angels or Demons in Patients With Attention-Deficit Hyperactivity Disorder? A Quasi-Systematic Review.