Clinical trial NCT05805176: An Adjunct Study to Assess Guided ADHD Therapy for Managing the Extent and Severity of Symptoms
Official title: An Adjunct Study to Assess Guided ADHD Therapy for Managing the Extent and Severity of Symptoms - A Prospective, Multicenter, Open Label, Single Arm, Intervention Study to Assess Efficacy and Safety of an At-home, Game-based Digital Therapy for Treating Clinical Symptoms of Adult Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: ADHD
Lead sponsor: Lumos Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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:

* 22-55 years of age (Cohort I) or 18-21 years of age (Cohort II)
* 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 total score on the DSM 5 Inattentive Symptoms, DSM 5 Hyperactive - Impulsive Symptoms and ADHD Index subscales of the Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) ≥24
* 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
* 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 daily
* Have access to a computer or smart device (e.g., phone, tablet) with internet access and a Google Chrome web browser
* Ability to comply with all the testing and study requirements

Exclusion Criteria:

* 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
* Inadequate IQ to participate in the study as estimated by Investigator (i.e., inability to read/understand the informed consent; inability to understand how the device and therapy (games) work)
* PHQ-9 scores ≥16
* 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 ADHD medication) 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: Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) Inattentive Symptoms subscale
timeFrame: Study Day 0 to Study Day 63
Secondary outcomes:
measure: Adult ADHD Self-Report Scale (ASRS) Inattentive Symptoms Subscale
timeFrame: Study Day 0 to Study Day 63
measure: Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) ADHD Symptoms Total subscale
timeFrame: Study Day 0 to Study Day 63
measure: Sheehan Disability Scale (SDS)
timeFrame: Study Day 0 to Study Day 63
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: CNS Healthcare of Jacksonville
state: Florida
city: Lakeland
country: United States
facility: Accel Clinical Research Sites
state: Florida
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine (RCBM)
state: Michigan
city: Brentwood
country: United States
facility: Midwest Research Group
state: Missouri
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
Study officials:
affiliation: Midwest Research Group
name: Greg Mattingly, MD
role: PRINCIPAL_INVESTIGATOR
References: