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临床试验/NCT05962216
NCT05962216招募中不适用

Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders: a Naturalistic Non-interventional Prospective Follow-up Study

Dr. Albert Kar-Kin Chung1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Change in Brief Psychiatric Rating Scale-24 in 6 months

研究概览

简要总结

Not only being the mainstay of treatment for schizophrenia spectrum psychotic disorders, antipsychotics, especially the second-generation antipsychotics (SGAs) have also been recommended as augmenting agents for treating depression. Dopaminergic agents, including both dopamine D2/D3 antagonists and dopamine partial D2 agonists, have been effective for treating psychosis and schizophrenia. Amongst all SGAs, those with partial D2 agonistic property are generally acknowledged to have better side-effect profiles with lower incidence of extrapyramidal side-effects, prolactin increase, weight gain, QTc prolongation, and metabolic syndrome, as well as more efficacious in alleviating depressive symptoms. Up-to-date, three SGAs, namely aripiprazole, brexpiprazole and cariprazine, are known to possess such partial D2 agonism. ReSD-HK study is part of the ReSD Asian Study aiming to carefully evaluate a cohort of patients prescribed with brexpiprazole on its efficacy and tolerability as treatment for schizophrenia and/or depression in a real-life clinical setting.

详细描述

This is a 6-month, non-interventional, prospective naturalist study that adult patients (18-65 years old) receiving brexpiprazole for treatment of psychosis and/or as adjunctive treatment for major depressive disorder are eligible to participate. Minimal exclusion criteria are employed to fit the usual real-life setting.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • Age: 18- 65 years old at the time of enrollment
  • Able to read and communicate in English and/or Chinese
  • Able to give informed consent
  • Has been diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), or International Statistical Classification of Diseases and Related Health Problems 10th revision (ICD-10) to have either Psychotic Disorders (F10-F19.5, F20-23, F25, F32-F33)
  • is receiving brexpiprazole as treatment for less than 4 weeks at the time of recruitment

排除标准

  • Age <18 years old
  • Unable to read English or Chinese
  • Unable to give informed consent
  • Had been diagnosed to have Intellectual Disabilities (DSM-5) or Mental Retardation (ICD-10 F70-73)

结局指标

主要结局

Change in Brief Psychiatric Rating Scale-24 in 6 months

时间窗: 6 months

Efficacy measures the change from baseline, to that at 3rd and 6th months

Change in Clinical Global Impression in 6 months

时间窗: 6 months

Efficacy measures the change from baseline, to that at 3rd and 6th months

Change in Beck Anxiety Inventory in 6 months

时间窗: 6 months

Efficacy measures the change from baseline, to that at 3rd and 6th months

Change in Beck Depression Inventory in 6 months

时间窗: 6 months

Efficacy measures the change from baseline, to that at 3rd and 6th months

Change in Digital Symbol Substitution Test in 6 months

时间窗: 6 months

Efficacy measures the change from baseline, to that at 3rd and 6th months

Change in World Health Organization Disability Assessment Schedule 2.0 in 6 months

时间窗: 6 months

Efficacy measures the change from baseline, to that at 3rd and 6th months

次要结局

  • Barnes Akathisia Rating Scale in 6 months(6 months)
  • Glasgow Antipsychotic Side-effects Scale in 6 months(6 months)
  • Simpson-Angus Scale in 6 months(6 months)

研究者

发起方
Dr. Albert Kar-Kin Chung
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Albert Kar-Kin Chung

Clinical Assistant Professor

The University of Hong Kong

研究点 (1)

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