临床试验/NCT06229210

NCT06229210招募中3 期

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder, or Autism Spectrum Disorder

Intra-Cellular Therapies, Inc.66 个研究点分布在 2 个国家目标入组 300 人开始时间: 2024年1月25日最近更新: 2026年8月28日

适应症

干预措施

试验速览

阶段: 3 期
状态: 招募中
发起方: Intra-Cellular Therapies, Inc.
入组人数: 300
试验地点: 66
主要终点: Incidence of Common Adverse Events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.

详细描述

The study will enroll pediatric patients as follows:

De Novo Patients:

Patients with schizophrenia, including patients who have previously participated in the lumateperone open-label pediatric pharmacokinetic (PK) study (Study ITI-007-020)
Patients with bipolar disorder who have previously participated in the lumateperone open-label pediatric PK study (Study ITI-007-030)
Patients with irritability associated with autism spectrum disorder who have previously participated in the lumateperone open-label pediatric PK study (Study ITI-007-035)

Rollover Patients:

Patients with bipolar disorder who are enrolling directly from a lead-in efficacy study.
Patients with irritability associated with autism spectrum disorder who are enrolling directly from a lead-in efficacy study.

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: 5 Years 至 17 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Able to provide consent as follows:
•The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent;
•The patient must provide written assent to study enrollment;
•Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder;
•Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).
•Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study.
•Rollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator.

排除标准

•Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolar II disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include:
•ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.
•For ASD patients only, based on Investigator opinion and DSM-5 criteria, mild or moderate intellectual disability is allowed. Severe or profound intellectual disability is exclusionary.
•In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or
•At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;
•At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
•At Screening or Baseline, scores > 3 on Item 13 (suicidal ideation) of the CDRS-R (for bipolar disorder patients only); or
•The patient is considered to be an imminent danger to him/herself or others.

研究组 & 干预措施

Lumateperone

Experimental

干预措施: Lumateperone (Drug)

结局指标

主要结局

Incidence of Common Adverse Events

时间窗: Up to 6 months

An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

次要结局

未报告次要终点

研究者

发起方

Intra-Cellular Therapies, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (66)

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