Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System

The Digital Medicine System includes a drug-device combination of aripiprazole + an
ingestible event marker (IEM), a wearable sensor (skin patch), and application software to
convey the level of activity and rest, and to mark events through the act of ingestion.

Physician and self-report are the most commonly used to assess medication compliance yet
studies have consistently found that healthcare providers' subjective judgments of medication
compliance are often inaccurate, with a tendency for practitioners to overestimate subject
adherence. The sponsor's intent is to develop a system that will benefit future subjects by
providing the ability to measure their medication-taking behavior in an objective manner and
being able to monitor several physiologic parameters.

Inclusion Criteria:

- Primary diagnosis of Schizophrenia (SCH), Major Depressive Disorder (MDD), or Bipolar
1 Disorder (BP1), per the Diagnostic and Statistical Manual of Mental Disorders, Fifth
Edition (DSM-5)

- Must be able to swallow tablets

- Currently taking a stable daily dose of oral aripiprazole

- Must have capacity to utilize the technology

- Skin in area of patch application must be free of any skin disorders or dermatological
problems

Exclusion Criteria:

- Subjects using long acting injectable antipsychotic medications

- Subjects likely to be incapable of using the Digital Medicine System even with
assistance

- Subjects who present serious risk of suicide

- History of epilepsy or seizures

- History of hypersensitivity to antipsychotic agents, adhesive tape or any component of
the sensor skin patch or ingestible event marker

- Current history of substance use disorder meeting DSM-5 criteria

- Subject with unstable mood, acute psychosis or exhibiting symptoms requiring
hospitalization