Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Psychosis NOS; Autistic Disorder; Asperger Syndrome; Child Development Disorders, Pervasive; Bipolar I Disorder; Bipolar II Disorder; Mood Disorder NOS; Severe Major Depression With Psychotic Features; Single Episode Major Depression Without Psychotic Symptoms; Severe Mood Disorder With Psychotic Features
MeSH terms: Depression; Depressive Disorder; Schizophrenia; Psychotic Disorders; Mental Disorders; Depressive Disorder, Major; Mood Disorders; Autistic Disorder; Asperger Syndrome; Developmental Disabilities; Child Development Disorders, Pervasive
Intervention: Latuda©
Intervention description: 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.
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 6 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: Latuda,lurasidone,antipsychotics,autism, mood, psychosis

Summary:

      The overarching purpose of this pilot study is to collect preliminary data regarding the
      variability of weight gain associated with lurasidone (Latuda©) treatment of antipsychotic
      naive children and adolescents in order to inform decisions about including a lurasidone arm
      in a future large scale trial of different approaches to minimize antipsychotic associated
      weight gain in the pediatric population. In adults, lurasidone appears to cause minimal
      weight gain. The participants will be 6-19 years old with psychotic spectrum, mood spectrum,
      or autism spectrum disorders. They will have 4 weeks or less of lifetime antipsychotic
      exposure.
    

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