CompletedPhase 2

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

United States9 participantsStarted 2012-12

Plain-language 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.

Who can participate

Age range6 Years – 19 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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©), halo…

What they're measuring

Change in Weight

Timeframe: Baseline to 12 weeks

Trial details

NCT IDNCT01731119

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-08

Results submitted2017-02-23