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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Foundation of Hope, North Carolina; Johns Hopkins University; The Zucker Hillside Hospital; University of Maryland
• Treatments: Antipsychotic Agents; Lurasidone Hydrochloride

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