NCT01683058已完成3 期
A 26-week, Multicenter, Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients With Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 主要终点
- Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Discontinued Investigational Medicinal Product (IMP) Due to AEs, Serious TEAEs and Outcome of Death
研究概览
简要总结
The phase 3 Trial 31-12-291 is part of the aripiprazole IM depot clinical development program and has been designed to demonstrate the efficacy and safety of aripiprazole IM depot for the treatment of adults experiencing an acute relapse of schizophrenia. Subjects receive treatment during a 12-week double-blind acute treatment phase. The current trial (31-12-297) will allow the subjects who complete Trial 291 to enter this open label trial at the investigator's discretion, where additional safety and tolerability data will be collected.
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
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects 18 to 66 years of age, inclusive, at the time of informed consent.
- •Subjects who are able to provide written informed consent (as required by IRB/IEC) prior to the initiation of any protocol-required procedures.
- •Ability, in the opinion of the investigator, to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medication, and to be reliably rated on assessment scales.
- •Subjects who have met the completion criteria in the 31-12-291 registrational trial for the acute treatment of adults with schizophrenia
- •Subjects who, in the investigator's judgment, require chronic treatment with antipsychotic medication and would benefit from extended treatment with an IM depot formulation.
- •Outpatient status at the Week 12 in Trial 291, with the exception of those subjects eligible to enter Trial 297 due to a positive interim analysis.
排除标准
- •Sexually active males of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 180 days after the last dose of trial medication. Sexually active Women of Childbearing Potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 150 days after the last dose of trial medication.
- •Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP in this trial.
- •Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that requires treatment with an antidepressant.
- •Subjects who are anticipated needing CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during the course of the trial.
- •Subjects with a significant risk of violent behavior; who represent a risk of committing suicide; or who in the clinical judgment of the investigator present a serious risk of suicide.
- •Subjects requiring any antipsychotic(s) other than aripiprazole IM depot after completion of Trial
- •Subjects likely to require prohibited concomitant therapy during the trial
- •Laboratory test and ECG results which are exclusionary
- •Any subject who, in the opinion of the investigator or medical monitor, should not participate in the trial
研究组 & 干预措施
Aripiprazole IM Depot
Experimental
Aripiprazole IM Depot 400 mg or 300 mg once monthly (every 28 days) for 24 weeks
干预措施: Aripiprazole IM Depot (Drug)
结局指标
主要结局
Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Discontinued Investigational Medicinal Product (IMP) Due to AEs, Serious TEAEs and Outcome of Death
时间窗: Baseline to Week 24
A TEAE was defined as an AE that began after the first injection or was continuous from Baseline and was serious, study drug-related, or resulted in death.
次要结局
- Mean Change From Baseline by Week by Extrapyramidal Symptoms (EPS) Evaluated Using the Simpson-Angus Scale (SAS)(Baseline to Week 24)
- Mean Change From Baseline by Week by EPS Evaluated Using Barnes Akathisia Rating Scale (BARS)(Baseline to Week 24)
- Mean Change in Heart Rate From Baseline in All Participants.(Baseline to last visit)
- Mean Change in Clinically Relevant Body Mass Index From Baseline in All Participants.(Baseline to last visit)
- Mean Change From Baseline in Suicidal Ideation Intensity Total Score by the Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline to Week 24)
- Mean Change From Baseline by Week by EPS Evaluated Using the Abnormal Involuntary Movement Scale (AIMS)(Baseline to Week 24)
- Mean Change in Body Temperature From Baseline in All Participants.(Baseline to last visit)
- Mean Change in Systolic Supine Blood Pressure (BP) From Baseline in All Participants.(Baseline to last visit)
- Mean Change in Diastolic BP From Baseline in All Participants.(Baseline to last visit)
- Mean Change in PR Interval From Baseline in All Participants.(Baseline to last visit)
- Mean Change in QTcF Interval From Baseline in All Participants.(Baseline to last visit)
- Mean Change in Clinically Relevant Body Weight Changes From Baseline in All Participants.(Baseline to last visit)
- Mean Change in Clinically Relevant Waist Circumference From Baseline in All Participants.(Baseline to last visit)
- Number of Participants With Clinically Relevant Laboratory Values.(Baseline to last visit)
- Number of Participants With Clinically Relevant Physical Examination.(Baseline to last visit)
- Mean Change in Heart Rate Supine From Baseline in All Participants.(Baseline to last visit)
- Mean Change in Systolic BP From Baseline in All Participants.(Baseline to last visit)
- Mean Change in RR Interval From Baseline in All Participants.(Baseline to last visit)
- Mean Change in QTcB Interval From Baseline in All Participants.(Baseline to last visit)
- Mean Change in QTcN Interval From Baseline in All Participants.(Baseline to last visit)
- Mean Change in Ventricular Rate From Baseline in All Participants.(Baseline to last visit)
- Mean Change in QT Interval From Baseline in All Participants.(Baseline to last visit)
- Mean Change in Diastolic Supine BP From Baseline in All Participants.(Baseline to last visit)
- Mean Change in QRS Interval From Baseline in All Participants.(Baseline to last visit)
研究者
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