Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents
|ClinicalTrials.gov Identifier: NCT01731119|
Recruitment Status : Completed
First Posted : November 21, 2012
Results First Posted : May 17, 2017
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Latuda©||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Pilot Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
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
- Change in Weight [ Time Frame: Baseline to 12 weeks ]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 ]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: Baseline to 12 weeks ]Efficacy measures included the Aberrant Behavior Checklist-Community (ABC-C) total score which focuses on problem behaviors in five subdomains, including irritability, attention, repetitive behaviors, unusual speech, and social withdrawal. Differences in subdomains were not assessed. The ABC-C total score is the sum of 58 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC-C total score ranges from 0 to 174. Higher values of ABC-C total scores represent greater severity of illness.
- Number of Participants Experiencing Side Effects [ Time Frame: Baseline to12 weeks ]Assessment of the medication side effects associated with lurasidone (Latuda©) in children and adolescents.
- Overall Clinical Improvement [ Time Frame: Baseline to 12 weeks ]Overall psychiatric functioning will be assessed with the improvement (CGI-I) subscales of the CGI. CGI-I items are rated from 1 (very much improved) to 7 (very much worse).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731119
|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|