EUCTR2012-004169-42-SK进行中（未招募）不适用
Interventional, open-label, long-term extension study to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in patients with major depressive disorder. - 14767B Open label extension protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,184
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator.
- •The patient had MDD at entry in lead-in brexpiprazole studies, 14570A or 14571A, diagnosed according to DSM-IV-TR™.
- •The patient agrees to protocol-defined use of effective contraception.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 554
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 630
排除标准
- •The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
- •The patient has been diagnosed with a psychiatric disorder other than MDD during the lead-in studies
- •14570A or 14571A.
- •The patient, in the opinion of the investigator or according to C-SSRS, is at significant risk of suicide.
- •The patient has any relevant medical history or current presence of systemic disease.
- •The patient has, at the Baseline Visit an abnormal ECG that is, in the investigator's opinion, clinically significant.
- •The patient has a moderate or severe ongoing adverse event related to study medication from the lead-in studies considered of potential safety risk by the investigator.
- •The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
研究者
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