Treatment Study Comparing Aripiprazole Once Monthly With Standard of Care Medication in Outpatients With Schizophrenia

Inclusion Criteria:

- Are able to provide written informed consent. If the Institutional Review Board (IRB)
requires consent by a legally acceptable representative in addition to the subject,
all required consents must be obtained prior to the initiation of any
protocol-required procedure.

- Are 18 to 60 years of age, inclusive, at the time of informed consent

- Has a current diagnosis of schizophrenia, as defined by DSM-V criteria and a history
of the illness for at least 6 months prior to screening from a reliable source (e.g.,
health care provider, family member, or medical records).

- Have been prescribed a single oral antipsychotic medication for at least 3 months
prior to screening.

- Are able to understand the nature of the study and follow protocol requirements,
including the prescribed dosage regimens, tablet ingestion, intramuscular (IM) once
monthly injection, and discontinuation of prohibited concomitant medications, read
and understand the written word in order to complete subject-reported outcomes
measures, and be reliably rated on assessment scales.

- Are male and female subjects who are surgically sterile (i.e., have undergone
orchiectomy or hysterectomy, respectively; female subjects who have been
postmenopausal for at least 12 consecutive months; or male and female subjects who
agree to remain abstinent or to practice double barrier forms of birth control from
study screening through 30 days (for females) and 90 days (for males) from the last
dose of study drug for SOC oral antipsychotics and 150 days for females and 180 days
for males for aripiprazole once monthly. If employing birth control, two of the
following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm,
intrauterine device, birth control pill, birth control implant, birth control once
monthly injections, condom, or sponge with spermicide.

Exclusion Criteria:

- Has a current DSM-V diagnosis other than schizophrenia, including schizophreniform
disorder, schizoaffective disorder, major depressive disorder, bipolar disorder,
delirium, dementia, amnestic or other cognitive disorders. Also excluded are subjects
with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial
personality disorder.

- Has had a psychiatric hospitalization within the 30 days prior to screening.

- Has received a depot antipsychotic within the 6 months prior to screening.

- Is considered resistant or refractory to antipsychotic treatment by history (failed
two prior antipsychotic medication studies) or response only to clozapine.

- Is taking two or more antipsychotics.

- Has a significant risk of violent behavior or a significant risk of committing
suicide based on history or investigator's discretion.

- Has a history of seizures or any other medical condition that would expose the
subject to undue risk or interfere with study assessments.

- Is involuntarily incarcerated or has been incarcerated in the past 6 months for any
reason.

- Has undergone electroconvulsive therapy in the 2 years prior to enrollment in the
study.

- Has used an investigational agent or has participated in a clinical study with
aripiprazole once monthly or any other antipsychotic once monthly preparation within
30 days of screening.

- Has any medical condition that might preclude safe completion of the study (e.g.,
agranulocytosis, severe and unstable heart disease, AIDS, end-stage renal disease).

- Is taking a CYP3A4 inducer (e.g., carbamazepine).