Phase 2 N=9 Treatment

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

Schizophrenia · Schizoaffective Disorder · Schizophreniform Disorder · Psychosis NOS · Autistic Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01731119 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Change in Weight — 0.70 lbs

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Latuda© (Drug)
Age: Pediatric, Adult · 6+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Weight	0.70	—
SECONDARY Proportion of Participants Completing Treatment	7	—
SECONDARY Changes in Efficacy Measures	-14	—
SECONDARY Number of Participants Experiencing Side Effects	3	—
SECONDARY Overall Clinical Improvement	2.67	—

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)
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01731119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.