Clinical trial NCT05296473: Guided ADHD Therapy for Managing the Extent and Severity of Symptoms
Official title: Guided ADHD Therapy for Managing the Extent and Severity of Symptoms - A Randomized, Controlled, Parallel-group, Intervention Study to Assess an At-home, Game-based Digital Therapy for Treating Adult Patients With Attention-Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: Lumos Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-25
Enrollment: 560
Sex: ALL
Minimum age (years): 22
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Test of Variables of Attention (TOVA®) Attention Comparison Score (ACS)
timeFrame: Study Day 0 to Study Day 63
Secondary outcomes:
measure: ADHD-RS-5 Inattention Subscale with Adult Prompts
timeFrame: Study Day 0 to Study Day 63
measure: Cambridge Brain Sciences Token Search
timeFrame: Study Day 0 to Study Day 63
measure: Cambridge Brain Sciences Spatial Span
timeFrame: Study Day 0 to Study Day 63
measure: Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Working Memory and Inhibit Percentiles
timeFrame: Study Day 0 to Study Day 63
measure: Weiss Functional Impairment Rating Scale - Self-Report (WFIRS-S)
timeFrame: Study Day 0 to Study Day 63
measure: Clinical Global Impression Scale - Improvement (CGI-I)
timeFrame: at Study Day 63
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Melmed Center
state: Arizona
city: Garden Grove
country: United States
facility: CNS Network
state: California
city: Sacramento
country: United States
facility: University of California Davis MIND Institute
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Maitland
country: United States
facility: Accel Research Sites - Maitland Clinical Research Unit
state: Florida
city: Saint Charles
country: United States
facility: Midwest Research Group
state: Missouri
city: Lincoln
country: United States
facility: Alivation Research, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Center of Psychiatry and Behavioral Medicine
state: Nevada
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Raleigh
country: United States
facility: Mindpath Care Centers
state: North Carolina
city: Memphis
country: United States
facility: CNS Healthcare
state: Tennessee
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
Study officials:
affiliation: Clinical Research of Southern Nevada, LLC
name: Ann Childress, MD
role: PRINCIPAL_INVESTIGATOR
References: