Intervention: Lurasidone Hydrochloride
Trial phase: Phase 2
SMILES: Cl.O=C1C2C3CCC(C3)C2C(=O)N1CC1CCCCC1CN1CCN(c2nsc3ccccc23)CC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.

Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.
Eligibility criteria:
Inclusion Criteria:

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

Subject must meet Diagnostic Statistical Manual (DSM)-IV-Text Revision (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 Not Otherwise Specified (NOS)
autistic disorder with significant irritability/aggression (Aberrant Behavioral Checklist-Community (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 Legally Authorized Representative (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