CTRI/2024/06/069258尚未招募3 期
A Phase 3, Randomized, Multi-Centric, Double-blind, Double Dummy, Active Controlled, Parallel Group, Clinical Study to Assess the Efficacy and Safety of Brexpiprazole in Comparison to Aripiprazole in Patients Suffering From Acute Schizophrenia
Torrent Pharmaceuticals Ltd.20 个研究点 分布在 1 个国家目标入组 304 人开始时间: 2024年6月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 304
- 试验地点
- 20
- 主要终点
- Mean change from baseline in positive and negative syndrome scale. PANSS
研究概览
简要总结
| This will be a randomized, multi-centric, double-blind, double-dummy, active controlled parallel-group clinical trial. The study will compare efficacy and safety of brexpiprazole with aripiprazole in patients with acute schizophrenia episode. A total of 304 patients with acute schizophrenia episode will be randomized. Patients will be enrolled in a ratio of 1:1 to receive either brexpiprazole tablet (test arm) or aripiprazole tablet (control arm). |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient or patient’s legally acceptable representative willing to give written informed consent to participate in the study.
- •Male or female patients of 18-65 years of age, both inclusive.
- •Patients meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for schizophrenia.
- •Patients newly diagnosed with acute schizophrenia or acute relapse of schizophrenia episodes.
- •Patients with a PANSS total score ≥ 70 at the time of screening.
- •Patients with a CGI-S score ≥ 4 at the time of screening.
- •Patient with relapse, who had received previous outpatient antipsychotic treatment at an adequate dose for the treatment of schizophrenia for an adequate duration and who showed a previous good response to such antipsychotic treatment (other than clozapine) in the 12 months prior to screening, according to the investigator’s opinion.
排除标准
- •Patients with a history of hypersensitivity to the study drugs or any of its excipients.
- •Patients with a history of being resistant/refractory to antipsychotic treatment.
- •Patients with a history of failure to respond to clozapine or respond to clozapine treatment only.
- •Patients already hospitalized or who required hospitalization for the treatment of a current episode of schizophrenia as per the investigator’s opinion.
- •Patients who had received electroconvulsive therapy in the past for treatment of schizophrenia episodes.
- •Elderly patients with dementia-related psychosis.
- •Patients with a diagnosis of mental retardation or other cognitive disorder, any other Axis I psychiatric diagnosis.
- •Patients currently receiving antipsychotic drug therapy.
- •Patients considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
- •Clinically significant suicidal or homicidal behavior or attempts within the past 6 months.
- •Patients who received clozapine for any reason other than schizophrenia within the last 4 months of randomization.
- •Patients who received treatment with mood stabilizers or antidepressants within 1 week, fluoxetine hydrochloride at any time within 1 month, or a monoamine oxidase (MAO) inhibitor within 3 weeks prior to screening.
- •Patients with a history of Neuroleptic Malignant Syndrome (NMS).
- •Patients with a history of pituitary adenoma.
- •Patients who have received or are currently receiving depot neuroleptics.
- •Patients with a surgical or medical condition that, in the judgment of the Investigator, could interfere with the absorption, distribution, metabolism, or excretion of the study drugs.
- •Patients with a history of alcohol and/or drug abuse within the past 12 months.
- •Patients with liver enzymes (alanine transaminase, aspartate transaminase, alkaline phosphatase) 2.5X the upper limit of normal value (ULN) or total bilirubin 1.5X of ULN or serum creatinine ULN and considered clinically significant by Investigator.
- •Patient with a history of HIV and/or HBV and/or HCV.
- •Patients who are on Insulin for the management of diabetes.
- •Patients with a history of ischemic heart disease or history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery.
- •Pregnant or lactating women or females of childbearing potential, who are neither surgically sterilized nor willing to use reliable contraceptive methods throughout the study duration or male subjects of childbearing potential not willing to use reliable contraception methods throughout the study duration.
- •Patients, in the opinion of the Investigator, are either unable to cooperate or unlikely to adhere to any study procedures.
结局指标
主要结局
Mean change from baseline in positive and negative syndrome scale. PANSS
时间窗: Â Week 6
次要结局
- The proportion of Subjects who experienced adverse events(AEs)(Week 6)
研究者
Dr Sanjay Maroo
Torrent Research Centre
研究点 (20)
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