An Open-Label Pilot Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in Weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Flexible Dose Latuda©
Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.
干预措施: Latuda© (Drug)
结局指标
主要结局
Change in Weight
时间窗: 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.
次要结局
- Changes in Efficacy Measures(Baseline to 12 weeks)
- Number of Participants Experiencing Side Effects(Baseline to12 weeks)
- Proportion of Participants Completing Treatment(12 weeks)
- Overall Clinical Improvement(Baseline to 12 weeks)