A 52-Week, Multicenter, Open-Label, Flexible-dose Study to Evaluate the Long-term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Subjects With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 42
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and tolerability of cariprazine in the treatment of pediatric participants with schizophrenia, bipolar I disorder, or autism spectrum disorder (ASD) and to establish the benefit-risk profile of long-term treatment in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia or bipolar I 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) at the Screening Visit 1 (for de novo subjects, or as previously confirmed in parent study for subjects who completed Study 3112-301-001 or M21-465).
- •De novo participants must have normal physical examination findings, clinical laboratory test results, and electrocardiogram (ECG) results at Screening Visit
- •Abnormal results must not be clinically significant as determined by the investigator. Participants enrolling after completion of Study M21-465 or 3112-301-001 have had monitoring of laboratory tests, physical examinations, and ECGs at the completion visit of the parent studies.
- •Participant must have a caregiver (parent or legally authorized representative) who is willing and able to be responsible for safety monitoring of the participant, provide information about the participant's condition, oversee administration of study intervention, and accompany the participant to all study visits.
排除标准
- •Participants with DSM-5-TR diagnosis of major depressive disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition. Participants with ASD that is associated with Rett disorder, fragile-X syndrome, or childhood disintegrative disorder.
- •Prior DSM-5-TR diagnosis of intellectual disability (IQ < 70) for schizophrenia and bipolar I disorder participants. Prior DSM-5-TR diagnosis of profound intellectual disability (IQ < 25) for ASD participants.
- •Participant has a condition or is in a situation, which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.
研究组 & 干预措施
Cariprazine Dose 1
Participants with Schizophrenia (age 13 to 17 years and < 40 kg body weight) will receive cariprazine.
干预措施: Cariprazine Flexible Dose (Drug)
Cariprazine Dose 2
Participants with Schizophrenia (age 13 to 17 years and >= 40 kg body weight) will receive cariprazine.
干预措施: Cariprazine Flexible Dose (Drug)
Cariprazine Dose 3
Participants with Bipolar I Disorder (age 10 to 12 years and <40 kg body weight) will receive cariprazine.
干预措施: Cariprazine Flexible Dose (Drug)
Cariprazine Dose 4
Participants with Bipolar I Disorder (age 10 to 12 years and >= 40 kg body weight) will receive cariprazine.
干预措施: Cariprazine Flexible Dose (Drug)
Cariprazine Dose 5
Participants with Bipolar I Disorder (age 13 to 17 years and < 40 kg body weight) will receive cariprazine.
干预措施: Cariprazine Flexible Dose (Drug)
Cariprazine Dose 6
Participants with Bipolar I Disorder (age 13 to 17 years and >= 40 kg body weight) will receive cariprazine.
干预措施: Cariprazine Flexible Dose (Drug)
Cariprazine Dose 7
Participants with Autism Spectrum Disorder ( age 5 to 9 years) will receive cariprazine.
干预措施: Cariprazine Flexible Dose (Drug)
Cariprazine Dose 8
Participants with Autism Spectrum Disorder (age 10 to 12 years and <40 kg weight) will receive cariprazine.
干预措施: Cariprazine Flexible Dose (Drug)
Cariprazine Dose 9
Participants with Autism Spectrum Disorder (age 10 to 12 years and >=40 kg body weight) will receive cariprazine.
干预措施: Cariprazine Flexible Dose (Drug)
Cariprazine Dose 10
Participants with Autism Spectrum Disorder (age 13 to 17 years and <40 kg weight) will receive cariprazine.
干预措施: Cariprazine Flexible Dose (Drug)
Cariprazine Dose 11
Participants with Autism Spectrum Disorder (age 13 to 17 years and >= 40 kg body weight) will receive cariprazine.
干预措施: Cariprazine Flexible Dose (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period
时间窗: Baseline Day 1 to Week 59
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug.
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
时间窗: Baseline Day 1 to Week 52
Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator assessed the results for clinical significance.
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
时间窗: Baseline Day 1 to Week 59
Vital sign parameters included blood pressure, pulse rate, body mass index (BMI), weight, and waist circumference. The investigator assessed the results for clinical significance.
Number of Participants With Suicidal Ideation or Suicidal Behavior as Recorded on the Columbia-Suicide Severity Rating (C-SSRS) Scale
时间窗: Baseline Day 1 to Week 52
C-SSRS is a clinician-rated scale that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 "wish to be dead," and 5 "active suicidal ideation with specific plan and intent". Suicidal behavior is classified on a 5-item scale: 0 "no suicidal behavior, and 4 "actual attempt".
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
时间窗: Baseline Day 1 to Week 52
AIMS assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. The first 10 items are rated on a none (0) to severe (4) scale. There are an additional 2 items on dental status that are answered yes or no.
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
时间窗: Baseline Day 1 to Week 52
BARS is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia (each on a 4-point scale from normal \[0\] to severe \[3\]). In addition, there is a global severity for akathisia rated on a 6-point scale (absent \[0\] to severe akathisia \[5\]).
Change From Baseline in Simpson-Angus Scale (SAS)
时间窗: Baseline Day 1 to Week 52
SAS is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Each item ranges from 0 (normal) to 4 (extreme symptoms). The scale consists of 1 item measuring gait (hypokinesia), 6 items measuring rigidity, and 3 items measuring glabella tap, tremor, and salivation, respectively.
Number of Participants With Clinically Significant Changes From Baseline in Opthalmologic Parameters
时间窗: Baseline Day 1 to Week 52
Ocular examination parameters included Intraocular pressure (IOP) measurement, Best-corrected visual acuity (BCVA), color fundus photography, color vision testing using Hardy Rand and Rittler (HRR) plates, and assessment of Optical coherence tomography (OCT) and cataracts. The investigator assessed the results for clinical significance.
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
时间窗: Baseline Day 1 to Week 52
A standard 12-lead ECG was performed. The investigator determined the clinical significance of the ECG findings using the central ECG interpretation laboratory report.
次要结局
未报告次要终点