Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents
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|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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|