A 6-Week, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Cariprazine in the Acute Exacerbation of Schizophrenia, With an Additional 18-Week Blinded Extension Period
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 34
- 试验地点
- 52
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. This study will assess how safe and effective cariprazine is in treating adult participants with schizophrenia in Japan and Taiwan. Adverse events and change in disease activity will be assessed.
Cariprazine (VRAYLAR) is an approved drug for the treatment of schizophrenia in the United States. In the first 6-week period, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In the next 18-week period, participants will have the option to receive 1 of 3 doses of cariprazine. Approximately 250 adult participants, 18-65 years of age with schizophrenia will be enrolled in approximately 55 sites across Taiwan and Japan.
Participants will receive oral capsules of Cariprazine or placebo for the 6-week Double-blind Period (DBP). Upon completion of 6-week DBP, participants will be eligible to receive oral capsules of Cariprazine for additional 18 weeks in the Blinded Extension Period (BEP), followed by an 8-week safety follow-up period.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
详细描述
Per the final protocol amendment 3, the number of dosing arms in the 6-week DBP of the study changed from 3 to 2. Participants enrolled in the study through Protocol Amendment 2 and who were randomized to the arm that was eliminated, remained in that arm through DBP and their data are displayed by that arm for the DBP portion of the study in participant flow, baseline characteristics and safety sections. Data for all endpoints are presented as planned per final SAP.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosed with schizophrenia at least 1 year before informed consent.
- •Experienced a persistent psychotic episode within 2 months prior to informed consent requiring treatment modifications as judged by the investigator or sub-investigator.
排除标准
- •- History of clinically significant medical conditions or any other reason that the investigator (or subinvestigator) determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study drug.
研究组 & 干预措施
Cariprazine
Participants will receive cariprazine Dose A daily for 6 weeks. Upon completion of 6 week treatment period, participants will have option to receive cariprazine Dose B for 18 weeks.
干预措施: Cariprazine (Drug)
Placebo
Participants will receive placebo daily for 6 weeks. Upon completion of 6 week treatment period, participants will have option to receive cariprazine Dose B for 18 weeks.
干预措施: Cariprazine (Drug)
Placebo
Participants will receive placebo daily for 6 weeks. Upon completion of 6 week treatment period, participants will have option to receive cariprazine Dose B for 18 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: From first dose of study drug until 8 weeks following last dose of study drug (up to 32 weeks)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Change in SCI-PANSS Total Score From Baseline (Wk 0) to Week 6.
时间窗: Baseline (Wk 0) to Week 6
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point scale with responses ranging from 1 (absent) to 7 (extreme). Higher values represent a worse outcome. The SCI-PANSS total score can range from 30 to 210. A negative change from baseline indicates improvement.
次要结局
- Change in CGI-S Score From Baseline (Wk 0) and Week 6 to Week 24(Baseline (Wk 0) and Week 6 to Week 24)
- Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) and Week 6 to Week 24(Baseline (Wk 0) and Week 6 to Week 24)
- Change in NSA-16 Total Score From Baseline (Wk 0) and Week 6 to Week 24(Baseline (Wk 0) and Week 6 to Week 24)
- Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) and Week 6 to Week 24(Baseline (Wk 0) and Week 6 to Week 24)
- Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) and Week 6 to Week 24(Baseline (Wk 0) and Week 6 to Week 24)
- Change in CGI-S Score From Baseline (Wk 0) to Week 6(Baseline (Wk 0) to Week 6)
- Change in SCI-PANSS Positive Symptom Score From Baseline (Wk 0) to Week 6(Baseline (Wk 0) to Week 6)
- Change in NSA-16 Total Score to Baseline (Wk 0) to Week 6(Baseline (Wk 0) to Week 6)
- Change in SCI-PANSS Negative Symptom Score From Baseline (Wk 0) to Week 6(Baseline (Wk 0) to Week 6)
- Change in SCI-PANSS Negative Factor Score From Baseline (Wk 0) to Week 6(Baseline (Wk 0) to Week 6)
- Change in SCI-PANSS Total Score From Baseline (Wk 0) and Week 6 to Week 24(Baseline (Wk 0) and Week 6 to Week 24)