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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This is a multi-site, 12-week, open-label study assessing the weight and metabolic changes
      associated with lurasidone treatment. Antipsychotic (AP) 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.
    

Intervention name(s): Latuda©
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Lurasidone Hydrochloride tablets
Intervention MeSH terms: Lurasidone Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Latuda,lurasidone,antipsychotics,autism, mood, psychosis