Study name: An Open-Label Pilot Study of Lurasidone in Treating Antipsychotic Naïve or Quasi-Naïve Children and Adolescents

Linmarie Sikich, MD
: Foundation of Hope
Contact person:
Lindsey Hazzard



The purpose of the proposed pilot study is to collect preliminary data to be used in the design of a larger multi-site randomized clinical trial. The purpose is to examine whether lurasidone (Latuda©) induces weight gain in children and adolescents ages 6-19. Participants must not have taken certain medications that are similar to Lurasidone (Latuda®) for more than 4 weeks. Similar medications include Risperdal®, Abilify®, Zyprexa®, Seroquel®, Geodon®, and Invega®.Participants must also have a diagnosis of either Schizophrenia, Schizophreniform, Schizoaffective, Psychosis NOS, Bipolar Disorder, Mood Disorder, Irritability, Depression, Autistic Disorder, Asperger’s, or PDD-NOS. The primary hypothesis is that Lurasidone induces minimal weight gain in these patients compared to other commonly prescribed antipsychotic medications.

Subject Payment

Participants will be provided with free and convenient parking. Study medication and research related services will be free of charge, and participants will be compensated $25 per visit.

Major Inclusion Criteria:

  • Male and female children and adolescents between 6 and 19 years of age of any race or ethnicity;
  • Subject must meet DSM-IV criteria for one of the following disorders: schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder NOS), mood spectrum disorder (bipolar type I, bipolar type II, mood disorder NOS, and severely mood dysregulated (SMD) broad spectrum bipolar disorder), autism spectrum disorder (autistic disorder, Asperger syndrome, and pervasive developmental disorder NOS) or major depressive disorder (with psychotic features or unresponsive to 2 different antidepressants)
  • Subjects must have ≤ 4 weeks of lifetime exposure to an antipsychotic medication at any dosage (AP quasi-naïve), or no lifetime exposure to any antipsychotic medication (AP naive). These medications include olanzapine (Zyprexa©), quetiapine (Seroquel©), risperidone (Risperdal©), ziprasidone (Geodon©), aripiprazole (Abilify©), asenapine (Saphris©), iloperidone (Fanapt©), lurasidone (Latuda©), paliperidone (Invega©), olanzapine/fluoxetine (Symbyax©), haloperidol, chlorpromazine, perphenazine, fluphenazine, thiothixene, and/or clozapine

Major Exclusion Criteria:

  • Current or past treatment with Lurasidone (Latuda®) that resulted in a non-response or intolerance

Target enrollment


Date enrollment closes



Latuda Study Brochure