Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adults With Schizophrenia On Oral Aripiprazole

Inclusion Criteria

• Subjects must be prepared and able to give written (signed and dated) informed consent, which includes adherence to study requirements and restrictions before enrolling in the study. Subjects must be willing to adhere to study procedures, including troubleshooting of the MIND1 System by a third party if needed (third party will be blinded to personal health information).
• Male and female subjects 18 to 65 years of age, inclusive, at time of informed consent.
• Subjects who have a primary current diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Subjects may be symptomatic at screening, but must be able to be treated as outpatients.
• Subject is cooperative, able to ingest oral medication, and willing to complete all aspects of study.
• Subject is currently prescribed oral aripiprazole for schizophrenia at one of the following single daily doses (10, 15, 20, or 30 mg), and is deemed likely to remain on this same stable dose throughout the course of the study. Subject has not had any changes in their aripiprazole regimen or dose over the 2 weeks before screening.
• Subject must be able and willing to carry the MIND1 System smartphone on his/her person and complete all tasks, as well as adequately operate all devices, as applicable. Caregiver or other third-party assistance can be utilized, if needed, although all subjects should be encouraged to attempt all tasks themselves.
• Subject likely possesses the capacity to utilize the technology interfaces (eg, open and navigate software applications using the touch screen) and telephone features of a smartphone. The subject has satisfactory mobile phone reception (preferably 3 bars or more, or have Wi-Fi) at home and/or at work for study-designated wireless carrier.
• Subject is not pregnant or breast-feeding, and does not plan to become pregnant.
• Skin on the anterior chest just above the lower edge of the rib cage that is free of any dermatological problems (eg, dermatosis or dermatitis, open wounds, or other skin disorders such as warts, rashes, atopic dermatitis, or irritations).

Exclusion Criteria

• Subjects with a current DSM-5 diagnosis other than schizophrenia, including major depressive disorder, bipolar disorder, schizoaffective disorder, delirium, major neurocognitive disorder (eg, dementia), intellectual developmental disorder, or any other diagnosis that might impact the subject's ability to participate in the study. Other disorders that are not the focus of treatment and will not impact the subject's ability to participate in all aspects of the study (eg, social anxiety disorder) may be included.
• Subjects with a current DSM-5 diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder.
• Subjects who exhibit prominent negative symptoms that, in the judgment of the investigator, will interfere with study procedures or unable to adhere with study requirements.
• Subjects who are currently on a long-acting injectable antipsychotic.
• Subjects who are likely to be incapable of using the MIND1 System technology, even with assistance.
• On the Columbia-Suicide Severity Rating Scale (C-SSRS) Subjects who answer "Yes" to Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) and whose most recent episode meeting criteria for this C-SSRS Item 4 occurred within the last 3 months, OR Subjects who answer "Yes" on the C-SSRS Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting criteria for this C-SSRS Item 5 occurred within the last 3 months, OR Subjects who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 1