Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents

This is a multi-site, 12-week, open-label study assessing the weight and metabolic changes
associated with lurasidone treatment. Antipsychotic naive subjects will start open-label
treatment by following a flexible titration schedule. Quasi-antipsychotic naive subjects
(less than 4 weeks of total AP treatment) will be started on lurasidone and tapered off the
other antipsychotic over an estimated 4 weeks depending on the dose and tolerability of the
prior antipsychotic. Other psychoactive medications including antidepressants,
benzodiazepines, stimulants, alpha-2 agonists, and mood stabilizers are allowed as long as
the dose is not changed, unless it is clinically necessary. Assessments of weight, efficacy,
and side effects are conducted at baseline, week 2, week 4, week 8, and week 12. The primary
outcome is percent change in weight. The secondary outcomes include psychiatric efficacy
measures and side effects.

Inclusion Criteria:

- Male and female children and adolescents between 6 and 19 years of age of any race or
ethnicity

- Subject must meet DSM-IV-TR criteria for a psychotic spectrum, mood spectrum or
autism spectrum disorder as defined by one of the following diagnoses:

- schizophrenia (any type)

- schizoaffective disorder

- schizophreniform disorder

- psychosis NOS

- autistic disorder with significant irritability/aggression (ABC-C Irritability
subscale score of greater than or equal to 18)

- Asperger syndrome with significant irritability/aggression (ABC-C Irritability
subscale score of greater than or equal to 18)

- pervasive developmental disorder NOS with significant irritability/aggression
(ABC-C Irritability subscale score of greater than or equal to 18)

- bipolar type I

- bipolar type II

- mood disorder NOS

- major depression with psychotic features

- major depression (unresponsive to 2 different antidepressants)

- severe mood dysregulation (SMD) according to Leibenluft and colleagues broad
spectrum bipolar disorder

- Subjects must have ≤ 4 weeks of lifetime exposure to an antipsychotic medication at
any dosage. These medications include olanzapine (Zyprexa©), quetiapine (Seroquel©),
risperidone (Risperdal©), ziprasidone (Geodon©), aripiprazole (Abilify©), asenapine
(Saphris©), iloperidone (Fanapt©), lurasidone (Latuda©), haloperidol, chlorpromazine,
perphenazine, fluphenazine, thiothixene, or clozapine

- Subjects on other psychoactive medications are asked not to change dose of those
medications during the course of the study unless clinically necessary

- Sexually active girls must agree to use two effective forms of birth control (i.e.
hormonal or spermicidal and barrier) or be abstinent)

- Primary caretaker is able to participate in study appointments as is clinically
indicated

- Ability of child to participate in all aspects of the protocol per investigator's
clinical judgment

- After considering all aspects of study participation the subject (if an adult) or
subject's parent or LAR must consent to participation

- After considering all aspects of study participation, the subject must assent to
participation if it is developmentally appropriate to obtain assent

Exclusion Criteria:

- Based on current or lifetime DSM-IV-TR criteria, a diagnosis of Eating Disorder
(Anorexia Nervosa or Bulimia Nervosa)

- Based on DSM-IV-TR criteria, a diagnosis of Substance Dependence Disorder (other than
tobacco dependence) within the past month

- Treatment with the following concomitant medications: strong CYP3A4 inhibitors (ex:
Ketoconazole), strong CYP3A4 inducers (ex: Rifampin)

- Current or past treatment with lurasidone (Latuda©) that resulted in a non-response
or intolerance

- Females who are pregnant or breast-feeding

- Ongoing or previously undisclosed child abuse requiring new department of social
service intervention

- Subjects who, in the Investigator's opinion, might not be suitable for the study