A Long-term, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Flexible-Dose Oral Aripiprazole (OPC-14597) as Maintenance Treatment in Adolescent Patients With Schizophrenia or Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 524
- 试验地点
- 3
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
This is an open-label study consisting of a screening period, a conversion/titration phase (Phase 1), an open-label treatment phase (Phase 2), and a follow-up period.
The study will enroll new subjects (hereafter referred as "de novo" subjects) with schizophrenia, or bipolar I disorder, manic or mixed episode with or without psychotic features, and rollover subjects with schizophrenia from 31-09-266 (hereafter referred to as "Study 266"). All de novo subjects must enter the screening period of the study. Subjects who are screened and are not required to go through Phase 1 will complete a Phase 2 baseline visit prior to their participation in Phase 2.
Study Design: Treatment, Single Group Assignment, Open Label, Active Control, Safety/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
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 13-17 years old (Schizophrenia); Subjects 10-17 years old (Bipolar manic or mixed episode)* [*Bulgaria will enroll Schizophrenia subjects only.]
- •Subjects with a current diagnosis of schizophrenia, and a history of the illness (diagnosis or symptoms) for at least 6 months prior to screening (as per subject, family, or healthcare provider, or by previous medical records).
- •Subjects with a current diagnosis of bipolar I disorder, manic or mixed episode with or without psychotic features (diagnosis or symptoms) experiencing symptoms for at least 1 week prior to screening. * [*These subjects will not be eligible to enroll in Bulgaria]
- •Subjects who have shown previous response to antipsychotic treatment (other than clozapine) and are not resistant to treatment with other antipsychotics.
- •Subjects who are currently being treated with oral antipsychotics other than clozapine, and are not resistant to treatment with other antipsychotics.
- •Inpatient or outpatient status, with the exception of acute hospitalization due to psychiatric reasons at the time of screening or before Phase 2.
排除标准
- •All subjects: diagnosis of schizoaffective disorder, autism, pervasive developmental disorder (PDD), OCD, or PTSD.
- •Subjects with schizophrenia: a current major depressive episode.
- •Subjects with bipolar manic or mixed episode: presenting with a clinical picture and/or history that is consistent with a diagnosis of bipolar II disorder or bipolar disorder not otherwise specified.
- •Subjects with delirium, dementia, amnesia or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (i.e., medication, illicit drug use, etc.).
- •Subjects with any neurological disorder, with the exception of Tourette's syndrome.
- •Subjects experiencing major depressive episode at the time of screening other than subjects diagnosed with bipolar I disorder mixed episode.
- •Subjects who are currently receiving clozapine or have received clozapine at any time in the past are ineligible for entry into the study.
- •Subjects who meet the DSM-IV-TR criteria for substance dependence (including alcohol and benzodiazepines, but excluding caffeine and nicotine) within the past 180 days prior to screening.
- •Subjects who have epilepsy, a history of seizures (except for a single childhood febrile seizure or post-traumatic seizure), or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions.
- •Subjects with a history of subclinical hypothyroidism (TSH ≥ 4.0 mIU/L), known hypothyroidism, or hyperthyroidism (unless the condition has been stabilized with medications for at least 90 days prior to entry into Phase 1 or Phase 2).
- •Subjects who have a medical history of uncontrolled diabetes, labile or unstable diabetes (brittle diabetes), newly diagnosed diabetes, or clinically significant abnormal blood glucose levels (defined as fasting blood glucose ≥ 125 mg/dL).
研究组 & 干预措施
Phase 1 and Phase 2
Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Adverse events were recorded from the time of the informed consent was signed throughout the 24 month treatment period until the follow-up visit 30 (± 3) days after the end of trial.
An AE was defined as any untoward medical occurrence in a participant or participant enrolled in a clinical trial and which did not necessarily have a causal relationship with the study medication. A treatment emergent adverse event (TEAE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study medication, whether or not considered to have a causal relationship with the study medication. A serious-AE or reaction was any untoward occurrence that, at any dose, was fatal, life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was any other medically significant event that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.
次要结局
- Incidence of Laboratory Values of Potential Clinical Relevance(Baseline to Month 24)
- Incidence of Physical Examination Findings of Potential Clinical Relevance(Baseline to Month 24)
- Incidence of Vital Signs of Potential Clinical Relevance(Baseline to Month 24)
- Mean Change From Baseline by Week in Abnormal Involuntary Movement Scale (AIMS)(Baseline to Month 24)
- Mean Change From Baseline by Week in Simpson-Angus Scale (SAS) Total Score(Baseline to Month 24)
- Mean Change From Baseline by Week in Barnes Akathisia Rating Scale (BARS) Score(Baseline to Month 24)
- Number of Participants With Cognitive Impairment for Each New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT)(Baseline to Month 24)
- Baseline and Post-Baseline Tanner Staging(Baseline to Last Visit)
- Incidence of Suicidality, Suicidal Behavior and Suicidal Ideation(Baseline to Month 24)
- Percentage of Participants Who Discontinued Due to All Adverse Events(Baseline to Month 24)
- Mean Change From Baseline in Positive and Negative Symptoms Score (PANSS) Total Score(Baseline to Month 24)
- Mean Change From Baseline for Columbia-Suicide Severity Rating Scale (C-SSRS) in Suicidal Ideation Intensity Total Score(Baseline to Month 24)
- Mean Change From Baseline in PANSS Positive Subscale Score(Baseline to Month 24)
- Mean Change From Baseline in PANSS Negative Subscale Score(Baseline to Month 24)
- Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score(Baseline to Month 24)
- Mean Change From Baseline in Children's Global Assessment Scale (CGAS) in Bipolar (de Novo Participants)(Baseline to Month 24)
- Mean Change in Clinical Global Impression-Improvement (CGI-I) Score(Baseline to Month 24)
- Mean Change From Baseline in Young Mania Rating Scale (YMRS) Score(Baseline to Month 24)
- Mean Change From Baseline in General Behavior Inventory (GBI) Scale Total Score for Mania and Depression in Both Parent/Guardian and Subject Version of the Scale(Baseline to Month 24)
- Mean Change From Baseline in Clinical Global Impression Scale - Bipolar (CGI-BP) Version Severity Score(Baseline to Month 24)
- Mean Change From Baseline in Clinical Global Impression Scale - Bipolar Version Improvement Score(Baseline to Month 24)
- Mean Change From Baseline in the Attention Deficit Hyperactive Disorders Rating (ADHD-RS-IV) Scale Score(Baseline to Month 24)