NCT01731119

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 6 Years – 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multi-site, 12-week, open-label study assessing the weight and metabolic changes associated with lurasidone treatment. Antipsychotic (AP) naive subjects will start open-label treatment by following a flexible titration schedule. Quasi-antipsychotic naive subjects (less than 4 weeks of total AP treatment) will be started on lurasidone and tapered off the other antipsychotic over an estimated 4 weeks depending on the dose and tolerability of the prior antipsychotic. Other psychoactive medications including antidepressants, benzodiazepines, stimulants, alpha-2 agonists, and mood stabilizers are allowed as long as the dose is not changed, unless it is clinically necessary. Assessments of weight, efficacy, and side effects are conducted at baseline, week 2, week 4, week 8, and week 12. The primary outcome is percent change in weight. The secondary outcomes include psychiatric efficacy measures and side effects.

Conditions

• Schizophrenia
• 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

Interventions

Type	Name	Description
DRUG	Latuda©	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.

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2012-11-21
• Last updated: 2017-06-14
• Results posted: 2017-05-17

Locations

1 site across 1 country: United States