An Adjunct Study to Assess Guided ADHD Therapy for Managing the Extent and Severity of Symptoms (NCT05805176) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
An Adjunct Study to Assess Guided ADHD Therapy for Managing the Extent and Severity of Symptoms
United States194 participantsStarted 2023-04-15
Plain-language 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).
Who can participate
Age range18 Years – 55 Years
SexALL
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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…
What they're measuring
1
Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) Inattentive Symptoms subscale