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

NCT01731119 | Completed Phase 2 Results

• 1 other identifier: 12-2302
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

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

Keywords

Latuda,lurasidone,antipsychotics,autism, mood, psychosis

Outcome Measures

Primary Outcomes (1)

• Change in Weight

  Change in weight from Baseline to Week 12 will be assessed as the primary outcome measure. Subjects will be asked to step on a special scale called a tanita which will calculate weight, fat mass at each study visit.

  Baseline to 12 weeks

Secondary Outcomes (4)

• Proportion of Participants Completing Treatment

  12 weeks

• Changes in Efficacy Measures

  Baseline to 12 weeks

• Number of Participants Experiencing Side Effects

  Baseline to12 weeks

• Overall Clinical Improvement

  Baseline to 12 weeks

Study Arms (1)

Flexible Dose Latuda©

EXPERIMENTAL

Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.

Drug: Latuda©

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.

Also known as: Lurasidone Hydrochloride tablets

Flexible Dose Latuda©

Eligibility Criteria

• Age: 6 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Foundation of Hope, North Carolina: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27517, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Mental Disorders; Autistic Disorder; Asperger Syndrome; Child Development Disorders, Pervasive; Bipolar Disorder; Mood Disorders

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Autism Spectrum Disorder; Neurodevelopmental Disorders; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Linmarie Sikich
• Organization: UNC-Chapel Hill

linmarie_sikich@med.unc.edu

Study Officials

• Linmarie Sikich, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 21, 2012
• Study Start: December 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: June 14, 2017
• Results First Posted: May 17, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)