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临床试验/NCT04051775
NCT04051775Unknown不适用

Non-Pharmacological Treatment of Psychosis

Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Serious adverse events

研究概览

简要总结

The objectives of the project are to investigate feasibility, safety, and health-related outcomes in patients with psychosis who choose not to use antipsychotic drugs (APs). The instruction from the Ministry of Health and Care Services to establish "Medication Free" (non-pharmacological (NonPharm)) treatment services, which has received substantial critique for being given without support in scientific evidence, provides a window of opportunity for research in an under-investigated field. The study will prospectively follow a cohort over 1 year who seeks NonPharm treatment, with repeated measurements of symptoms, functional outcomes, quality of life, adverse events, as well as biological parameters including genetics and brain imaging, and environmental factors, and compare the findings to a control group of users of antipsychotic drugs, matched for age, gender and diagnosis. Current unanswered questions in the treatment of psychosis include which patients can successfully and safely discontinue antipsychotic medication; and what are the long-term symptomatic, biological and functional outcomes after use or non-use of APs, respectively. Taken together there is a fundamental lack of high-quality evidence to guide the treatment options in people who cannot or do not want to use APs in psychosis. This is also a major challenge in the study, as a more rigorous design that could directly compare different treatment options is not feasible, because no alternatives to APs have proven to be sufficiently effective and safe in controlled trials. The study is accordingly expected to provide new exploratory information that could be the basis of intervention studies which in its turn could provide important information for consumers and the mental health services regarding treatment options in psychosis.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Fulfillment of diagnostic criteria for schizophrenia or related disorder (corresponding to chapter F2 in the ICD-10)
  • The clinician responsible for the treatment must consider nonpharmacological treatment to be professionally justifiable in the patient in question
  • Patient being able/ capable of providing informed consent
  • Patient receiving active treatment including different psychosocial treatments
  • Patient having a treatment plan and a crisis resolution plan.
  • Exclusion Criteria Not fullfilling inclusion criteria

排除标准

  • 未提供

结局指标

主要结局

Serious adverse events

时间窗: One year

To investigate the prevalence of any Serious Adverse Events (SAE) in the NorPharm group compared to the control group

次要结局

  • Time to relapse(One year)
  • Time to recovery(One year)
  • Insight(One year)
  • Time to remission(One year)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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