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.
Schizophrenia (Any Type)
Autistic Disorder With Significant Irritability/Aggression
Asperger Syndrome With Significant Irritability/Aggression
Pervasive Developmental Disorder NOS (PDD-NOS) With Significant Irritability/Aggression
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)
|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: Open-Label, Flexible Dose Lurasidone
The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant. For antipsychotic naive subjects, no other antipsychotic treatment will be allowed during the course of study participation. For quasi-antipsychotic naive subjects, titration will begin in conjunction with the down titration of their current AP. The goal would be to have the subject be completely discontinued from their current AP and on lurasidone solely by week 4, but this may be extended based on clinical need.
All subjects will be started on 20-40mg of lurasidone 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.
|Contact: Lindsey M Hazzard, LCSW||(919) firstname.lastname@example.org|
|Contact: Cheryl O Alderman, BS||(919) email@example.com|
|United States, Maryland|
|Johns Hopkins University||Not yet recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Courtney P Keeton, PhD 410-614-5174 firstname.lastname@example.org|
|Contact: Erin Santana, BS (410) 614-6028 email@example.com|
|Principal Investigator: Mark Riddle, MD|
|University of Maryland||Not yet recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Kristin Bussell, MS 410-328-9087 Kbussell@psych.umaryland.edu|
|Principal Investigator: Gloria Reeves, MD|
|United States, New York|
|The Zucker Hillside Hospital||Not yet recruiting|
|Glen Oaks, New York, United States, 11004|
|Contact: Sandeep Kapoor, MD 718-470-8751 firstname.lastname@example.org|
|Contact: Eva Sheridan, MD (718) 470-4391 email@example.com|
|Principal Investigator: Christoph Correll, MD|
|United States, North Carolina|
|University of North Carolina||Recruiting|
|Chapel Hill, North Carolina, United States, 27517|
|Contact: Lindsey M Hazzard, LCSW 919-972-7440 firstname.lastname@example.org|
|Contact: Cheryl O Alderman, BS (919) 972-7447 email@example.com|
|Principal Investigator: Linmarie Sikich, MD|
|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|