Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents
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.
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
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Pilot Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents|
- Change in Weight [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]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.
- Proportion of Participants Completing Treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Data will be collected on why participants terminated the study. If terminated early, the specific reason will be collected such as efficacy or tolerability.
- Changes in Efficacy Measures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- Side Effects [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Assessment of the medication side effects associated with lurasidone (Latuda©) in children and adolescents.
- Overall Clinical Improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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).
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Flexible Dose Latuda©
Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.
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.
Other Name: Lurasidone Hydrochloride tablets
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731119
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21205|
|University of Maryland|
|Baltimore, Maryland, United States, 21205|
|United States, New York|
|The Zucker Hillside Hospital|
|Glen Oaks, New York, United States, 11004|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27517|
|Principal Investigator:||Linmarie Sikich, MD||University of North Carolina, Chapel Hill|
|Principal Investigator:||Mark Riddle, MD||Johns Hopkins University|
|Principal Investigator:||Christoph Correll, MD||The Zucker Hillside Hospital|
|Principal Investigator:||Gloria Reeves, MD||University of Maryland|