EUCTR2012-002252-17-CZ进行中（未招募）1 期
Interventional, randomised, double-blind, parallel-group, placebo-controlled, active-reference, flexible-dose study of brexpiprazole in patients with acute schizophrenia - 14644A Protocol
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 468
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 has schizophrenia, diagnosed according to DSM-IV-TR™ and
- •confirmed by the Mini International Neuropsychiatric Interview (MINI).
- •The patient has an acute exacerbation of psychotic symptoms and marked
- •deterioration of usual function.
- •The patient is willing to be hospitalised from the Screening Visit through
- •The patient will benefit from hospitalisation or continued hospitalisation for
- •treatment of a current acute relapse of schizophrenia at study entry.
- •The patient has a history of relapse and/or exacerbation of symptoms when
- •not receiving antipsychotic treatment, excluding the current episode.
- •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 455
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •The patient has a current Axis I diagnosis (DSM-IV-TR™ criteria) other
- •than schizophrenia established as primary diagnosis.
- •The patient suffers from a current Axis II diagnosis (DSM-IV-TR™
- •The patient suffers from mental retardation, organic mental disorders, or
- •mental disorders due to a general medical condition (DSM-IV-TR™
- •The patient, in the opinion of the investigator or according to Columbia
- •Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
- •The patient has clinically significant tardive dyskinesia or severe akathisia
- •at enrolment.
- •The patient has a history of neuroleptic malignant syndrome.
- •The patient has any relevant medical history or current presence of systemic
- •The patient has, at the Screening Visit an abnormal ECG or other abnormal
- •ECG tests that are, in the investigator's opinion, clinically significant.
- •The patient has a history of cancer, other than basal cell or Stage 1
- •squamous cell carcinoma of the skin, that has not been in remission for >5
- •years prior to the first dose of brexpiprazole.
- •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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