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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731119
• Other study ID #: 12-2302
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2012
• Last updated: August 24, 2014
• Start date: December 2012
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

This is a multi-site, 12-week, open-label study assessing the weight and metabolic changes associated with lurasidone treatment. Antipsychotic 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 19 Years

Eligibility

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-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 NOS

• autistic disorder with significant irritability/aggression (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 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)

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asperger Syndrome
• Autistic Disorder
• Bipolar I Disorder
• Bipolar II Disorder
• Child Development Disorders, Pervasive
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Developmental Disabilities
• Disease
• Mental Disorders
• Mood Disorder NOS
• Mood Disorders
• Psychosis NOS
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder
• Severe Major Depression With Psychotic Features
• Severe Mood Disorder With Psychotic Features
• Single Episode Major Depression Without Psychotic Symptoms

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	University of North Carolina	Chapel Hill	North Carolina
United States	The Zucker Hillside Hospital	Glen Oaks	New York

Sponsors (5)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Foundation of Hope, North Carolina, Johns Hopkins University, The Zucker Hillside Hospital, University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight	Percent 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.	12 weeks	Yes
Secondary	Proportion of Participants Completing Treatment	Data will be collected on why participants terminated the study. If terminated early, the specific reason will be collected such as efficacy or tolerability.	12 weeks	No
Secondary	Changes in Efficacy Measures	Efficacy measures including the Brief Psychiatric Rating Scale (BPRS-C) which measures symptomatology on five subscales including depression/anxiety, psychomotor excitation/mania, behavior problems, thinking disturbance, and organicity and the Aberrant Behavior Checklist-Community (ABC-C) which focuses on problem behaviors in five subdomains, including irritability, attention, repetitive behaviors, unusual speech, and social withdrawal.	12 weeks	No
Secondary	Side Effects	Assessment of the medication side effects associated with lurasidone (Latuda©) in children and adolescents.	12 weeks	Yes
Secondary	Overall Clinical Improvement	Overall psychiatric functioning will be assessed with the severity (CGI-S) and improvement (CGI-I) subscales of the CGI. CGI-S items are rated from 1 (normal, not ill) to 7 (very severely ill). CGI-I items are rated from 1 (very much improved) to 7 (very much worse).	12 weeks	No