A Phase II, Proof-of-concept, National, Multicenter, Randomized, Double-blind Clinical Trial to Compare the Efficacy and Safety of WAS123 Versus Daily Aripiprazole in the Maintenance Treatment of Patients With Schizophrenia.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Score PANSS
研究概览
简要总结
A phase II, proof-of-concept, national, multicenter, randomized, double-blind clinical trial to compare the efficacy and safety of WAS123 in the maintenance treatment of patients with schizophrenia, with a parallel design between 2 groups and controlled by an active comparator (Aripiprazole).
A total of 121 participants were randomized and assigned to either 1 of 2 treatment groups in a 1:1 ratio.
详细描述
Aripiprazole is an atypical antipsychotic for the maintenance treatment of acute and chronic schizophrenia and bipolar 1 disorder in adults. This was a phase II, proof-of-concept, national, multicenter, randomized, double-blind clinical trial to compare the efficacy and safety of WAS123 in the maintenance treatment of patients with schizophrenia, with a parallel design between 2 groups and controlled by an active comparator (Aripiprazole).
Primary Objective: To evaluate the non-inferiority in efficacy of the WAS123 compared to the dosage of Aripiprazole in the overall symptomatic control of participants with schizophrenia.
Methodology: A total of 121 participants were randomized, and assigned to 1 of the 2 treatment arms of the trial in a 1:1 ratio.
This was a double-blind trial, no participant or person involved in its conduct, including those people responsible for data management, were aware of the allocation of treatments to participants.
Diagnosis and Main Criteria for Inclusion and Exclusion: The trial target population was made up of adults of both sexes aged 18 or over and 65 or under diagnosed with schizophrenia according to the DSM-5 diagnostic criteria. Participants were ineligible if they had another psychiatric disorder with psychotic symptoms other than schizophrenia or with schizophrenia refractory or resistant to antipsychotic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 18 to 65 years with the ability to confirm voluntary participation and who agreed to all trial purposes by signing and dating the ICF in duplicate.
- •Diagnosis of schizophrenia according to DSM-5 diagnostic criteria and who:
- •At Screening:
- •Were stable on aripiprazole, considering a minimum period of 4 weeks without dose adjustment, or
- •Had an inadequate response to another antipsychotic; or
- •Had tolerance issues (e.g., extrapyramidal symptoms, metabolic problems) with the current antipsychotic; or
- •Were treatment-naive
- •At randomization:
- •Were stable on aripiprazole, considering a minimum period of 4 weeks without dose adjustment.
- •Participants who met all of the following criteria were considered stable:
- •Not hospitalized;
- •Total Positive and Negative Syndrome Scale (PANSS) score ≤80;
- •Score ≤4 on individual PANSS items (P1, P2, P3, and P6);
- •CGI-S score ≤4 (moderately ill);
- •CGI-SS score ≤2 (mildly suicidal)
排除标准
- •Any clinical or laboratory findings that were interpreted by the principal investigator as a risk to the participant's participation in the clinical trial or the presence of uncontrolled chronic disease(s);
- •Participants with schizophrenia refractory or resistant to antipsychotic treatment (therapeutic failure with 2 different antipsychotics, after treatment for at least 4 weeks at the maximum tolerated dose);
- •Participants who had not responded adequately to previous aripiprazole trials;
- •Participants who had used depot antipsychotics or undergone electroconvulsive therapy in the last 3 months;
- •History of organic mental disorders, moderate to severe intellectual disability, or another psychiatric disorder with psychotic symptoms other than schizophrenia;
- •History of epilepsy, neuroleptic malignant syndrome, clinically relevant tardive dyskinesia, or other medical condition that would expose the participant to undue risk or interfere with trial assessments;
- •Diagnosis of substance dependence, including alcohol and benzodiazepines, but excluding nicotine and caffeine;
- •Participants with previous cardiac events, such as tachycardia or bradyarrhythmias, or any significant prolongation of the QT interval on the electrocardiogram (ECG);
- •Participants who were pregnant, breastfeeding, or planning to become pregnant, or female participants of childbearing potential who were not using a reliable method of contraception;
- •Participants with known allergy or hypersensitivity to the components of the medications used during the clinical trial;
- •Research participant who participated in clinical trial protocols in the last 12 months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator considered that there could be direct benefit to them.
研究组 & 干预措施
WAS123
oral dose
干预措施: WAS123 (Drug)
Aripiprazole
oral daily dose
干预措施: Aripiprazole (Fixed dose) (Drug)
结局指标
主要结局
Score PANSS
时间窗: From enrollment to the end of treatment at 12 weeks
To evaluate the non-inferiority in efficacy of the WAS123 compared to the dosage of Aripiprazole in the overall symptomatic control of participants with schizophrenia.
次要结局
未报告次要终点