DIMES - DIgital MEdicine Study for Adults With Schizophrenia, Bipolar I Disorder, or Major Depression Currently Using Aripiprazole

This is a phase 4, 12-month, pragmatic trial designed to assess adherence in patients using
ABILIFY MYCITE versus patients receiving treatment as usual (TAU). Both groups will complete
surveys at baseline, 90, 180, and 360 days and will receive care at the discretion of their
physician. The usual care group will not receive the ABILIFY MYCITE intervention. The primary
outcome will assess refill rates at 6 months.

Eligible patients will enroll at their screening/baseline visit and ABILIFY MYCITE onboarding
will be provided in the clinic, with commercial informational materials and additional call
center support. Patients will then initiate 3 months of treatment with ABILIFY MYCITE at the
baseline visit. At the Day 90 visit, patients will have the opportunity to either stop or
continue using ABILIFY MYCITE for the remainder of the study (9 months). This decision must
be a joint decision with the patient and his or her treating physician. During this optional
interventional phase, patients may start and stop ABILIFY MYCITE as clinically indicated.

All enrolled patients will have required in-person visits at baseline, 90-days, and 180-days.
The day 360 (final) visit can be in-person or via telephone.

Medical and actual pharmacy dispensing data will be collected from day 1 through day 360
using the VA's electronic medical record system.

Inclusion Criteria:

- Patients aged 18 years of age or older.

- Patients with a primary diagnosis of schizophrenia (including schizoaffective
disorder), bipolar I disorder, or major depressive disorder based on the Diagnostic
Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria.

- Patients have an active prescription for oral Aripiprazole.

- Patients may have general medical conditions that are deemed safe for the patient to
enter an interventional trial per investigator judgment.

- Patients deemed fit for participation in the study by verbal or written confirmation
from their mental health provider

Exclusion Criteria:

- Patients with a current neurocognitive disorder (i.e. dementia), intellectual
disorder, or any other diagnosis that could impact the patient's ability to
participate in the trial.

- Any patient who, in the opinion of the patient's mental health provider, study
physician or investigator, is unfit to participate in the trial.

- Any patient who has participated in an investigational drug trial 30 days prior to
trial enrollment.

- Females who are breastfeeding, and/or who have a positive pregnancy test prior to
trial enrollment, or females who are planning to become pregnant during the trial. No
clinical trials have been conducted on the use of ABILIFY MYCITE during pregnancy or
breastfeeding.

- Patients who do not have skin on the anterior chest just above the lower edge of the
rib cage that is free of any dermatological problems (e.g., dermatosis or dermatitis,
open wounds, or other skin disorders such as warts, rashes, atopic dermatitis, or
irritations).

- Patients who are unwilling to refrain from the use of topical products on the skin
patch sites.

- Has 2 or more errors on the brief, 6-item cognitive screener administered at baseline.

- <20% Proportion of Days Covered (PDC) Aripiprazole over the last 6 months prior to
enrollment. This is to ensure that all individuals enrolled will have at least filled
their Aripiprazole prescription.