Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents

Study Description

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Brief Summary:

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.

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

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	9 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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

Arms and Interventions

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Arm

Intervention/treatment

Experimental: Flexible Dose Latuda©; Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.

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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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).

Eligibility Criteria

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Ages Eligible for Study:	6 Years to 19 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27517

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Foundation of Hope, North Carolina

Investigators

Principal Investigator:	Linmarie Sikich, MD	University of North Carolina, Chapel Hill

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT01731119 History of Changes
Other Study ID Numbers:	12-2302
First Posted:	November 21, 2012
Results First Posted:	May 17, 2017
Last Update Posted:	June 14, 2017
Last Verified:	April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by University of North Carolina, Chapel Hill:

Latuda,lurasidone,antipsychotics,autism, mood, psychosis

Additional relevant MeSH terms:

Disease; Depression; Depressive Disorder; Schizophrenia; Psychotic Disorders; Mental Disorders; Depressive Disorder, Major; Mood Disorders; Autistic Disorder; Asperger Syndrome; Developmental Disabilities; Child Development Disorders, Pervasive; Pathologic Processes; Behavioral Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders

Neurodevelopmental Disorders; Antipsychotic Agents; Lurasidone Hydrochloride; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs; Adrenergic alpha-2 Receptor Antagonists; Adrenergic alpha-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists