Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adults With Schizophrenia On Oral Aripiprazole
Condition: Schizophrenia; Mental Disorder; Nervous System Diseases
MeSH terms: Nervous System Diseases; Schizophrenia; Mental Disorders
Intervention: MIND1 System
Intervention description: Subjects will receive aripiprazole tablets embedded with an IEM. They will discontinue their normally prescribed oral aripiprazole tablets and will take the aripiprazole + IEM tablets (eg, at the previously prescribed dose) during the 8-week treatment period for this study. Aripiprazole + IEM tablets must be taken on a once-daily dosing schedule.
Intervention MeSH terms: Aripiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: OPC-14597 Digital; Aripiprazole; Medical Information Device #1 System (MIND1); Treatment Adherence; Ingestible Event Marker

Summary:

      The purpose of this study is to determine the usability of the Medical Information Device #1
      (MIND1) system in adults with schizophrenia who are treated with oral aripiprazole.
    

Eligibility criteria:

        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 year, OR Subjects who, in the opinion of the
             investigator, present a serious risk of suicide.

          -  Subject has received any investigational product within the last 30 days, including
             the MIND1 System (eg, subjects who participated in Cohort 1 of this study are not
             eligible for Cohort 2).

          -  Subjects who have a history or evidence of a medical condition that would expose them
             to an undue risk of a significant AE or interfere with assessments of safety or
             usability during the course of the study, including but not limited to, hepatic,
             renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic
             disease, as determined by the clinical judgment of the investigator.

          -  Subjects with epilepsy or a history of seizures (except for a single childhood febrile
             seizure, post traumatic seizure, alcohol withdrawal seizure, etc).

          -  Subjects with a history of neuroleptic malignant syndrome or clinically significant
             tardive dyskinesia, as assessed by the investigator.

          -  Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment
             with aripiprazole or other quinolinones.

          -  Subjects with a history of hypersensitivity to antipsychotic agents.

          -  Subjects with a known allergy to adhesive tape or any pertinent components of the
             patch or IEM

          -  Sexually active women of childbearing potential who will not commit to utilizing 2 of
             the approved birth control methods or who will not remain abstinent during this study
             and for 30 days following the last dose of study medication.

          -  Sexually active males (unless sterile, defined as having had a bilateral orchiectomy)
             who will not commit to utilizing 2 of the approved birth control methods or who will
             not remain abstinent during the study and for 90 days following the last dose of study
             drug.

          -  Subject has a current history (within the past month) of a substance use disorder
             (excluding tobacco) which meets DSM-5 criteria, or demonstrates a positive result on
             the urine drug test during screening. Subjects with a positive drug screen for drugs
             of abuse (excluding cannabinoids) are excluded and may not be retested or rescreened.
             Subjects with a positive urine drug screen resulting from use of prescription (such as
             opioids) or over-the-counter medications or products that, in the investigator's
             documented opinion, do not signal a clinical condition that would impact the safety of
             the subject or interpretation of the study results may continue evaluation for the
             study following consultation and approval by the Medical Monitor.

          -  Subjects who, in the opinion of the investigator, are acutely psychotic or who exhibit
             symptoms currently requiring hospitalization.

          -  Subjects unwilling to refrain from the use of topical products on the skin patch
             sites.

          -  Subjects unwilling or unable to complete the evaluations included in this study, which
             include audio recording of the subject's voice and require the ability to distinguish
             colors (eg, subjects unwilling to be recorded and colorblind subjects are to be
             excluded from participation in this study)

          -  Any subject who, in the opinion of the investigator, should not participate in the
             study.