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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

November 14, 2012
November 21, 2012
February 23, 2017
May 17, 2017
June 14, 2017
December 2012
August 2014   (Final data collection date for primary outcome measure)
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.
Change in Weight [ Time Frame: 12 weeks ]
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.
Complete list of historical versions of study NCT01731119 on ClinicalTrials.gov Archive Site
  • 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).
  • 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: 12 weeks ]
    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 ]
    Assessment of the medication side effects associated with lurasidone (Latuda©) in children and adolescents.
  • Overall Clinical Improvement [ Time Frame: 12 weeks ]
    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).
Not Provided
Not Provided
 
Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents
An Open-Label Pilot 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.
This is a multi-site, 12-week, open-label study assessing the weight and metabolic changes associated with lurasidone treatment. Antipsychotic (AP) 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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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©
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
Experimental: Flexible Dose Latuda©
Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.
Intervention: Drug: Latuda©
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
August 2014
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female children and adolescents between 6 and 19 years of age of any race or ethnicity
  • Subject must meet Diagnostic Statistical Manual (DSM)-IV-Text Revision (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 Not Otherwise Specified (NOS)
    • autistic disorder with significant irritability/aggression (Aberrant Behavioral Checklist-Community (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 Legally Authorized Representative (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
Sexes Eligible for Study: All
6 Years to 19 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01731119
12-2302
No
Not Provided
Plan to Share IPD: No
University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Foundation of Hope, North Carolina
Principal Investigator: Linmarie Sikich, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP