NCT02892422已完成3 期
Interventional, Open-label, Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult 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
- 528
- 试验地点
- 102
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
研究概览
简要总结
To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.
详细描述
Safety study in patients with schizophrenia who have participated and completed a study investigating Lu AF35700 including Studies 16159A and 16323A. Or in patients with schizophrenia for whom a switch of antipsychotic treatment can be potentially beneficial according to the investigator's clinical judgement.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For 16159A-patients
- •The patient has completed Study 16159A.
- •The patient is able to read and understand the Informed Consent Form.
- •The patient has signed the Informed Consent Form specific for Study 16159B.
- •The patient can potentially benefit from 52-week treatment with Lu AF35700 according to the investigator's clinical judgement.
- •For 16323A-patients
- •The patient has completed the dosing period of Study 16323A.
- •The patient is able to read and understand the Informed Consent Form.
- •The patient has signed the Informed Consent Form specific Study 16159B.
- •The patient has a confirmed diagnosis of schizophrenia according to DSM-5™.
- •The patient can potentially benefit from 52-week treatment with Lu AF35700 according to the investigator's clinical judgement.
- •For Other Patients
- •The patient has schizophrenia, diagnosed according to DSM-5™.
- •The patient is a man or woman, aged ≥18 years.
- •The patient has been prescribed oral antipsychotic treatment at the recommended dose range as stated in the summary of product characteristics or equivalent label for 6 weeks prior to the Screening Visit.
- •The patient has a PANSS total score ≥60 and ≤90 at Screening and Baseline Visits.
- •The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≤
- •The patient is in need of a change in the current antipsychotic treatment and, according to the investigator's clinical judgement, the patient can potentially benefit from a switch to another treatment including, but not limited to, any of the following reasons:
- •lack of adequate response to his or her current antipsychotic medication;
- •poor tolerability to his or her current antipsychotic medication;
- •unwillingness of the patient to adhere to his or her current antipsychotic medication.
排除标准
- •For 16159A-patients
- •The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16159A.
- •The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers "Yes" to any question on the Suicidal Behaviour section of the Columbia-Suicide Severity Rating Scale (C-SSRS), OR Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
- •For 16323A-patients
- •The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16323A.
- •The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers "Yes" to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
- •For Other Patients
- •The patient has any current psychiatric disorder (DSM-5™ criteria) other than schizophrenia established as the primary diagnosis.
- •The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit, between the Screening and Baseline Visits or at the Baseline Visit.
- •The patient is treated with clozapine at the time of the Screening Visit.
- •The patient has a substance use disorder (except nicotine) which according to the investigator's judgment may compromise the patient's ability to comply with the study procedures, or preclude the benefits of the study medication.
- •The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers "Yes" to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
- •Other protocol defined inclusion and exclusion criteria may apply
研究组 & 干预措施
Flexible-dose of Lu AF35700
Experimental
干预措施: Lu AF35700 (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability)
时间窗: From dosing to end of study (57 weeks)
Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight, waist circumference and ECG)
次要结局
未报告次要终点
研究者
研究点 (102)
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