Pediatric Schizophrenia Efficacy and Safety Study

To evaluate the efficacy of lurasidone (40 mg/day and 80 mg/day) compared with placebo in
adolescent subjects with schizophrenia (diagnosed by Diagnostic and Statistical Manual of
Mental Disorders, 4th Ed., Text Revision [DSM-IV-TR] criteria) as measured by the change
from Baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6.

Inclusion Criteria:

- Written informed consent from parent(s) or legal guardian(s) with sufficient
intellectual capacity to understand the study and support subjects' adherence to the
study procedures must be obtained for subjects who are not emancipated. In accordance
with Institutional Review Board (IRB) requirements, the subject will complete an
informed assent prior to study participation.

- Male or female subjects 13 to 17 years of age, inclusive, at the time of consent.

- DSM-IV-TR axis I primary diagnosis of schizophrenia (including disorganized (295.10),
paranoid (295.30), undifferentiated (295.90) subtypes) and confirmation of the
schizophrenia diagnosis by an adequately trained clinician at the time of screening,
by means of the Schedule for Affective Disorders and Schizophrenia for School-age
Children (K-SADS-PL).

- PANSS total score ≥ 70 at screening and Baseline.

- CGI-S ≥ 4 at screening and Baseline.

- Within 5th to 95th percentile for gender specific weight-for-age and height-for-age
Growth Charts from National Center for Health Statistics.

- In good physical health on the basis of medical history, physical examination, and
laboratory screening.

- Females who participate in this study:

are unable to become pregnant (eg, premenarchal, surgically sterile, etc.); -OR-

practices true abstinence (consistent with lifestyle) and must agree to remain abstinent
from signing informed consent to at least 30 days after the last dose of study drug has
been taken;

-OR-

are sexually active and willing to use a medically effective method of birth control
(e.g., male using condom and female using condom, diaphragm, contraceptive sponge,
spermicide, contraceptive pill, or intrauterine device) from signing informed consent to
at least 7 days after the last dose of study drug has been taken.

- Males must be willing to remain sexually abstinent (consistent with lifestyle) or use
an effective method of birth control (eg, male using condom and female using condom,
diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine
device) from signing informed consent to at least 30 days after the last dose of
study drug has been taken.

- In the judgement of the clinician, the subject has an acute exacerbation of psychotic
symptoms (no longer than 2 months in duration) and marked deterioration of function
from baseline (by history) or, the subject has been hospitalized for the purpose of
treating an acute psychotic exacerbation for 2 consecutive weeks or less immediately
before screening.

- In the judgment of the investigator, the subject is able to swallow the size and
number of study drug tablets specified per protocol.

- Willing and able to adhere to protocol-specified meal requirements during dosing.

Exclusion Criteria:

- Has an Axis I or Axis II diagnosis other than schizophrenia that has been the primary
focus of treatment within 3 months of screening.

- Has a history or current diagnosis of mental retardation, neuroleptic malignant
syndrome, or any neurologic disorder, or severe head trauma.

- Lifetime history of human immunodeficiency virus (HIV) positive or acquired immune
deficiency syndrome (AIDS), or history of Hepatitis B or C.

- Any of the following:

Documented history of chromosomal disorder with developmental impairment (ie, trisomy
chromosome 21; 22q11 deletion syndrome).

Evidence of any chronic organic disease of the CNS such as tumors, inflammation, active
seizure disorder, vascular disorder, potential CNS related disorders that might occur in
childhood- eg, Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or
serious neuromuscular disorders. In addition, subjects must not have a history of
persistent neurological symptoms attributable to serious head injury. Past history of
febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is not exclusionary.

- PANSS total scores ≥ 120 at screening or Baseline.

- Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive
dyskinesia, or any other moderate or severe movement disorder. Severity to be
determined by the investigator.

- Lifetime history of electroconvulsive therapy (ECT).

- Resistant to antipsychotic treatment based on at least two different prior adequate
trials (ie, adequate dose and duration) of an antipsychotic agent within the current
episode of schizophrenia.

- Clinically significant neurological, metabolic (including type 1 diabetes), hepatic,
renal, hematological, pulmonary, cardiovascular, gastrointestinal, carcinoma, and/or
urological disorder that would pose a risk to the subjects if they were to
participate in the study or that might confound the results of the study.

Note: Active medical conditions that are minor or well-controlled are not exclusionary if
they do not affect risk to the subject or the study results. In cases in which the impact
of the condition upon risk to the subject or study results is unclear, the Medical Monitor
should be consulted. Any subject with a known cardiovascular disease or condition (even if
controlled) must be discussed with the Medical Monitor during screening.

- Has a history of malignancy < 5 years prior to signing the informed consent.

- Clinically significant finding(s) on physical examination determined by the
investigator to pose a health concern to the subject while on study.

- Clinically relevant abnormal laboratory values or abnormal vital sign
values/findings.

Note: If any laboratory results are outside the normal range, the site may have the
subject retested. If upon retesting the value remains outside the normal range, the
significance of this value must be discussed with the Medical Monitor for enrollment
consideration.

- A history or presence of abnormal ECG, which in the investigator's opinion is
clinically significant. Abnormal screening ECGs will be centrally over-read, and
eligibility will be determined based on the over-read.

- Presence or history (within the last year) of a medical or surgical condition (eg,
gastrointestinal disease) that might interfere with the absorption, metabolism, or
excretion of orally administered lurasidone.

- Clinically significant alcohol abuse/dependence or drug abuse/dependence based on
DSM-IV-TR criteria within the last 6 months prior to screening.

- Positive test results at screening or Baseline for:

1. Urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine,
opiates, phencyclidine, cannabinoids, and methadone). A positive test for
amphetamines, barbiturates, opiates, benzodiazepines or methadone may not result
in exclusion of subjects if the investigator determines that the positive test
is as a result of taking prescription medicine(s) as prescribed. In the event a
subject tests positive for cannabinoids (tetrahydrocannabinol) or alcohol, the
investigator will evaluate the subject's ability to abstain from prohibited
substances during the study. If in the investigator's clinical judgment the
subject will abstain, the subject may be enrolled after consultation with the
Medical Monitor.

2. Pregnancy test.

- Females who are pregnant, lactating, or likely to become pregnant during the study.

- Participated in another interventional clinical trial or receiving an investigational
product within 30 days prior to randomization.

- Donation of whole blood within 60 days prior to randomization.

- Known history or presence of clinically significant intolerance to any antipsychotic
medications including but not limited to angioedema, serotonin or neuroleptic
malignant syndromes.

- Clinically relevant history of drug hypersensitivity to lurasidone or any components
in the formulation.

- Use of concomitant medications that consistently prolong the QT/QTc interval within
28 days prior to randomization.

- Received depot neuroleptics unless the last injection was at least 1 month or 1
treatment cycle prior to screening, whichever is longer.

- Received treatment with antidepressants, stimulants, or atomoxetine within 3 days
prior to randomization, fluoxetine hydrochloride within 21 days of randomization,
monoamine oxidase (MAO) inhibitor within 28 days of randomization, or clozapine
within 120 days of randomization.

- Use of any antipsychotic medication (other than study drug), carbamazepine,
oxcarbazepine, eslicarbazepine acetate, or fluvoxamine, within 3 days prior to
randomization (7 days prior to randomization for aripiprazole) and until follow-up.

- Has a prolactin concentration ≥ 100 ng/mL at screening, or has a history of pituitary
adenoma.

- At screening or Baseline the subject answers "yes" to "Suicidal Ideation" Items 4 or
5 on the C-SSRS.

- Subject is considered by the investigator to be at imminent risk of suicide or injury
to self, others, or property during the study. Subject has a history of one or more
serious suicide attempts (based on the investigator's judgment) in the 3 months prior
to screening. Subjects determined to be at risk of suicide or injury, as assessed by
the investigator at screening, will be referred for further psychiatric evaluation.

- Adhering to a special diet for the 28 days prior to drug administration (eg, liquid,
protein, raw food diet).

- Subject is planning to move during the study, is chronically homeless, or is unable
to attend all planned study visits. The Medical Monitor will be consulted for
individual cases, as needed.

- Demonstrates a decrease (improvement) of > 25% in the PANSS score between screening
and Baseline visits.

- Subject with newly diagnosed Type 2 diabetes during screening. A subject with Type 2
diabetes is eligible for study inclusion if considered clinically stable, which is
defined as:

Random (non-fasting) screening glucose is < 200 mg/dl (11.1 mmol/L); and If ≥ 200 mg/dL
(11.1 mmol/L) must be retested in a fasted state. Retested fasted value cannot be ≥ 126
mg/dL.

HbA1c ≤ 6.5%; and If a subject is currently being treated with oral anti-diabetic
medication(s), the dose must have been stable for at least 4 weeks prior to screening.
Such medication may be adjusted or discontinued during the study, as clinically indicated.

- Subject has required hospitalization for diabetes or related complications in the
past 12 months.

- Subject requires use of concomitant medications that are potent inducers or
inhibitors of the cytochrome P450 (CYP) 3A4 enzyme system (Appendix C) from signing
informed consent until follow-up.

- Clinically significant orthostatic hypotension (ie., a drop in systolic blood
pressure of 20 mmHg or more and/or drop in diastolic blood pressure of 10 mmHg or
more within 4 minutes of standing up).