CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Latuda©drug
Likely dose
Latuda© 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01731119
NCT01731119Phase 2Completed
CompareCT.gov

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

University of North Carolina, Chapel Hill·interventional·Posted Nov 21, 2012·Updated Jun 14, 2017

In Brief

A Phase 2 clinical trial evaluating Latuda© for Schizophrenia and 12 related conditions. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, 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
CountriesUnited States
CollaboratorsFoundation of Hope, North Carolina

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 21, 2012
Enrollment StartDec 1, 2012
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.6 years ago

Interventions

Latuda©drug

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.