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

This study is currently recruiting participants.
Verified January 2013 by University of North Carolina, Chapel Hill
Sponsor:
Collaborators:
Foundation of Hope, North Carolina
Johns Hopkins University
University of Maryland
The Zucker Hillside Hospital
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01731119
First received: November 14, 2012
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Schizophrenia (Any Type)
Schizoaffective Disorder
Schizophreniform Disorder
Psychosis NOS
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)
 Drug: Latuda©
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 30
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)
Arms Assigned Interventions
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.
 Drug: Latuda©
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 19 Years
Genders Eligible for Study:   Both
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 DSM-IV-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 NOS
    • autistic disorder with significant irritability/aggression (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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731119

Contacts
Contact: Lindsey M Hazzard, LCSW (919) 972-7440 lhazzard@med.unc.edu
Contact: Cheryl O Alderman, BS (919) 972-7447 cheryl_alderman@med.unc.edu

Locations
United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21205
Contact: Courtney P Keeton, PhD     410-614-5174     ckeeton@jhmi.edu    
Contact: Erin Santana, BS     (410) 614-6028     esantan1@jhmi.edu    
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     skapoor@nshs.edu    
Contact: Eva Sheridan, MD     (718) 470-4391     eschenk@nshs.edu    
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     lhazzard@med.unc.edu    
Contact: Cheryl O Alderman, BS     (919) 972-7447     cheryl_alderman@med.unc.edu    
Principal Investigator: Linmarie Sikich, MD            
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Foundation of Hope, North Carolina
Johns Hopkins University
University of Maryland
The Zucker Hillside Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Linmarie Sikich, MD, Associate Professor of Psychiatry, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01731119     History of Changes
Other Study ID Numbers: 12-2302
Study First Received: November 14, 2012
Last Updated: January 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of North Carolina, Chapel Hill:
Latuda, lurasidone, weight gain, second generation antipsychotics, behavioral medications, autism, mood, psychosis, depression

Additional relevant MeSH terms:
Asperger Syndrome
Aggression
Autistic Disorder
Developmental Disabilities
Depression
Depressive Disorder
Mental Disorders
Psychotic Disorders
Schizophrenia
Depressive Disorder, Major
Child Development Disorders, Pervasive
Mood Disorders
 Behavioral Symptoms
Mental Disorders Diagnosed in Childhood
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 17, 2013