A Trial to Measure the Difference in All-cause Hospitalizations for Patients Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder

This is a phase 4, open-label, prospective, pragmatic clinical trial to assess the difference
between all-cause hospitalizations in patients using Abilify MyCite (for Months 1-3, then
prohibited for Months 4-6) versus virtual matched controls from baseline to Day 180. Virtual
matched controls would be receiving treatment as usual (ie, any product other than Abilify
MyCite, which may be oral aripiprazole or any other product). Eligible patients will enter a
screening period of up to 13 days. For patients enrolling into the study, those not on
aripiprazole at screening will use the screening period for conversion to aripiprazole from
other antipsychotics. At the baseline visit, Abilify MyCite onboarding will be provided in
the office, then, patients will initiate 3 months of treatment with Abilify MyCite. During
the following 3 months (Months 4-6), use of Abilify MyCite will be prohibited (and the
patient continues with oral aripiprazole or other appropriate treatment, per routine clinical
care).

After the visit at Day 180, a second, optional interventional period (up to 6 months of
Abilify MyCite) may be initiated per the joint decision of the patients with their study
physician; patients in this second, optional interventional period will have a visit at Day
360. During this second, optional interventional period, patients may start and stop Abilify
MyCite as clinically indicated.

In addition, there will be a parallel exploratory study, which will utilize a different set
of physicians and patients from the main study. Results from the exploratory study will be
analyzed separately from the main study results.

Procedures for the exploratory study will be similar to those in the main study, with the
exception that there will be 1-month intervals of Abilify MyCite use (and 1-month intervals
of prohibition of Abilify MyCite use). During periods of nonuse of Abilify MyCite, the
patient continues with oral aripiprazole treatment, per routine clinical care.

In the exploratory study, each patient will receive Abilify MyCite per 1 one of 2 sequences
over a 360-day period: Sequence 1: Only in Months 1, 2, 5, and 10, Sequence 2: Only in Months
1, 4, 7, and 10. Sites will be randomized to 1 of the 2 sequences. For this exploratory
study, the site visits will be at screening, baseline, Day 180, and Day 360. The exploratory
arm will begin after the main study is enrolled at approximately 50% (ie, staggered start).

Inclusion Criteria:

- Patients are actively enrolled in an Anthem-affiliated commercial, Medicaid, or
Medicare health plan with medical and pharmacy benefits.

- Patients must have a smartphone with data plan.

- Patients currently prescribed aripiprazole, or appropriate for aripiprazole treatment.

- Patients must have a current diagnosis of SCH, BP1, or MDD.

Exclusion Criteria:

- Any patient who participated in another clinical trial within 30 days of enrollment
into the current study.

- Females who are breast-feeding and/or who are pregnant at the time of study
enrollment, or who plan to become pregnant during the study.

- Patients who are currently being treated with a long-acting injectable antipsychotic.