Study of the Impact of Aripiprazole (Abilify®) Once Monthly Versus Standard of Care Oral Antipsychotic Medications on Changes in Brain Structure and Metabolism

Inclusion Criteria for All Subjects

- Are able to provide written informed consent.

- Are male and female subjects 18 to 35 years of age, inclusive, at time of informed
consent.

Inclusion Criteria for Subjects with Schizophrenia

- Have a current diagnosis of schizophrenia as defined by DSM IV-TR criteria and a
history of the illness for at least 1 year prior to screening and at least two prior
psychotic episodes based on medical records or a qualified and reliable health care
provider.

- Require, in the investigator's judgment, chronic treatment with an antipsychotic
medication.

- Are able to understand the nature of the study and follow protocol requirements,
including the prescribed dosage regimens, tablet ingestion, IM depot 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
trial screening through 30 days (for females) and 90 days (for males) from the last
dose of IMP for SOC oral antipsychotics and 150 days for females and 180 days for
males for aripiprazole depot. 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 depot injections,
condom, or sponge with spermicide.

Exclusion Criteria All Subjects

- Presence of any metal implants, pacemakers, unremovable prosthetic device, or other
device or situation that may preclude imaging

- History of a head injury with loss of consciousness > 5 minutes

- Has a significant medical condition that would expose the subject to undue risk or
interfere with study assessments.

Exclusion Criteria for Subjects with Schizophrenia

- Has a current DSM-IV-TR 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.

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

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

- Has met DSM-IV-TR criteria for any significant substance use disorder within 3 months
prior to screening, excluding caffeine, nicotine, or marijuana.

- Is known to be allergic, intolerant, or unresponsive to prior treatment with
aripiprazole or other quinolinones, or hypersensitivity to antipsychotic agents,
including aripiprazole.

- Has a history of neuroleptic malignant syndrome or clinically significant tardive
dyskinesia at screening per the 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.

- 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 IM depot or any other antipsychotic depot preparation within 30 days of
screening.

- Has clinically significant abnormalities in laboratory test results, vital signs, or
ECG results.

- Requires more than one benzodiazepine beyond screening (e.g., lorazepam and oxazepam).

- Fails to washout from prohibited concomitant medications, including the use of or
CYP3A4 inducers, a second antipsychotic, antidepressants (including monoamine oxidase
inhibitors), and mood stabilizers.