Guided ADHD Therapy for Managing the Extent and Severity of Symptoms

NCT ID: NCT05296473

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 560 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-05
• Study Completion Date: 2024-03-12

Brief Summary

The objective of this study is to assess the safety and effectiveness of an at-home, game-based digital therapy for treating adult patients with Attention-Deficit/Hyperactivity Disorder (ADHD).

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ADHD Therapy

Group Type: EXPERIMENTAL

ADHD Therapy

Intervention Type: DEVICE

investigational game-play therapy

Control Therapy

Group Type: ACTIVE_COMPARATOR

Control Therapy

Intervention Type: DEVICE

control game-play therapy

Interventions

ADHD Therapy

investigational game-play therapy

Intervention Type: DEVICE

Control Therapy

control game-play therapy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects 22-55 years of age
• Male or female
• Confirmed ADHD diagnosis, combined or inattentive type, at Screening based on DSM-5 criteria and established via the MINI-Adult, administered by a trained clinician
• Baseline score on the clinician-rated ADHD-RS total score ≥28
• Not undergoing pharmacological treatment with methylphenidate or amphetamine-based products at time of Screening; or, if undergoing pharmacological treatment, must be willing and appropriate (i.e., not optimally treated in the Investigator's judgement or having issues with tolerability) to wash out of current regimen
• Estimated IQ score ≥80 as assessed by the Kaufmann Brief Intelligence Test, Second Edition (KBIT-II)
• Ability to understand and speak English, follow written and verbal instructions (English), as assessed by the PI and/or Study Coordinator, and give informed consent (English)
• Have ability to connect wireless devices to a functional wireless network on a daily basis
• Ability to comply with all the testing and study requirements

Exclusion Criteria

• Current, controlled (requiring restricted medication) or uncontrolled, comorbid psychiatric diagnosis, based on MINI-Adult and subsequent clinical interviewing, with significant symptoms including but not limited to posttraumatic stress disorder, psychosis, bipolar illness, pervasive developmental 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.
• Patients who are currently treated with a non-stimulant medication for ADHD (i.e., atomoxetine, clonidine, guanfacine, viloxazine)
• Have previously been assessed by TOVA for potential enrollment in a clinical trial.
• Have previously used a videogame-like digital therapy (e.g., Akili EndeavorRxTM) OR Within the last three years, have used a cognitive or brain training platform (e.g., Peak, Brain HQ, Lumosity, Atentiv) for more than two weeks duration
• Known sensitivity to playing video games, such as headaches, dizziness, nausea.
• Initiation within the last 4 weeks of behavioral therapy or neurofeedback, or planned initiation during the study. Patients who have been in behavior therapy or neurofeedback consistently for more than 4 weeks may participate provided their routine is unchanged during the course of the study. Patients planning on changing or initiating behavior therapy or neurofeedback during the course of the study will be excluded.
• Patient is currently considered a suicide risk in the opinion of the Investigator, as measured by C-SSRS at screening (i.e., score of 4 or 5 on C-SSRS)
• Motor condition (e.g., physical deformity of the hands/arms; protheses) that prevents game playing as observed by the Investigator
• Recent history (within the past 12 months) of suspected alcohol or substance abuse or dependence
• Positive urine drug screen
• History of seizures (excluding febrile seizures), or significant motor or vocal tics, including but not limited to Tourette's Disorder and photo-sensitive epilepsy
• Visual acuity that cannot be corrected that prevents or negatively impacts game playing as observed by the Investigator
• Any use of psychoactive drugs (other than stimulant) that in the opinion of the Investigator may confound study data/assessments
• Has participated in a clinical trial within 90 days prior to screening
• Has a family member or close friend/associate also enrolled/currently participating in the same study
• Any other condition that in the opinion of the Investigator may confound study data/assessments

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumos Labs, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann Childress, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research of Southern Nevada, LLC

Locations

Melmed Center

Scottsdale, Arizona, United States

CNS Network

Garden Grove, California, United States

University of California Davis MIND Institute

Sacramento, California, United States

University of California San Francisco

San Francisco, California, United States

Accel Research Sites - Maitland Clinical Research Unit

Maitland, Florida, United States

Midwest Research Group

Saint Charles, Missouri, United States

Alivation Research, LLC

Lincoln, Nebraska, United States

Center of Psychiatry and Behavioral Medicine

Las Vegas, Nevada, United States

Center for Emotional Fitness

Cherry Hill, New Jersey, United States

Duke University

Durham, North Carolina, United States

Mindpath Care Centers

Raleigh, North Carolina, United States

CNS Healthcare

Memphis, Tennessee, United States

FutureSearch Trials of Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

CIP-013

Identifier Type: -

Identifier Source: org_study_id