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临床试验/NCT07716969
NCT07716969招募中不适用

Duration of Untreated Psychosis Revisited - Testing the Effect of Early Detection Services on the Duration of Untreated Psychosis. the TOPUS Study

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
2
主要终点
Duration of Untreated Psychosis measured with the NOS

研究概览

简要总结

This study examines whether an early-detection program for psychosis can shorten the time patients remain untreated after the first appearance of psychotic symptoms, and whether such a reduction improves later functioning for people with first-episode schizophrenia.

Psychosis involves symptoms such as hallucinations and delusions. When these symptoms are recognized and treatment begins, most patients improve. However, many individuals live with psychotic symptoms for months-or even longer-before receiving care. This period is known as the duration of untreated psychosis (DUP). A long DUP has repeatedly been linked to poorer long-term outcomes, but it is still unclear whether DUP itself causes worse outcomes or simply reflects different illness courses.

In Denmark, Region Zealand has implemented a large-scale early-detection effort. This includes public awareness campaigns and a specialized team that identifies people with emerging psychosis and helps them start treatment quickly. The Capital Region of Denmark provides usual care without these additional initiatives. This situation makes it possible to compare two regional systems that differ in their approach to early detection but provide the same specialized treatment once patients enter care.

The study follows a quasi-experimental design, recruiting adults (18+) who receive a first diagnosis of a schizophrenia-spectrum disorder within the OPUS early-intervention programs in the two regions. No interventions are assigned by the research team; participants receive standard clinical care. Researchers conduct interviews to establish how long psychotic symptoms were present before treatment began and to assess functioning and symptoms over a two-year follow-up period. Functioning, symptoms, cognition, and treatment factors will be examined at baseline and at follow-ups.

The study addresses three questions:

Whether early-detection efforts in Region Zealand reduce the duration of untreated psychosis compared with usual detection.

Whether a shorter duration of untreated psychosis leads to better functional and clinical outcomes fifteen months after treatment begins.

How DUP can best be defined and measured so that it reliably predicts later outcomes.

Results may provide evidence for whether early-detection services improve timely access to care and whether reducing the duration of untreated psychosis contributes to better long-term functioning. The study may also help establish clearer international standards for how DUP should be measured in both research and clinical practice.

详细描述

This study investigates whether a large-scale early-detection program for psychosis implemented in one Danish health region reduces the duration of untreated psychosis (DUP) and whether a shorter DUP leads to improved clinical and functional outcomes. The project takes advantage of an existing difference between two regions in Denmark: Region Zealand has, for more than a decade, operated campaign-supported early-detection teams, whereas the Capital Region provides standard detection pathways without additional outreach. Both regions deliver identical specialized treatment once patients enter the OPUS early-intervention services. This natural difference creates a unique opportunity to evaluate the real-world impact of early-detection efforts.

Scientific Rationale

DUP refers to the time between the onset of psychotic symptoms and the start of appropriate treatment. Prolonged DUP is consistently associated with worse outcomes, including more severe symptoms and poorer functioning. However, most existing evidence comes from observational studies that cannot rule out the possibility that long DUP is simply a marker of more severe or insidiously developing illness rather than a direct causal factor. The field therefore lacks strong evidence on whether active reduction of DUP improves outcomes.

Some early-detection initiatives-most prominently the TIPS study-have demonstrated that campaigns combined with rapid-access teams can significantly reduce DUP and may influence long-term functioning. However, not all attempts to reduce DUP have succeeded, and no consensus exists on the most effective strategy. It also remains uncertain how DUP should best be defined and operationalized, as several different definitions are used in the literature.

The present study is designed to help address these gaps. It examines whether an established early-detection strategy in Region Zealand has in fact shortened DUP compared with usual detection, whether any reduction has meaningful effects on two-year outcome trajectories, and which definitions of DUP provide the most reliable predictive value.

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 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18 or older In treatement in an OPUS treatment center in The Capital Region or Region Zealand.
  • Started OPUS treatment within the last 9 months Suspected to have a psychotic disorder within the ICD 10 Schizophrenia spectrum (DF2X, excluding schizotypal disorder and schizophrenia simplex) Able to communicate adequately regarding symptoms and functioning in Danish or English.

排除标准

  • IQ bellow 70 I primary diagnoses of drug or alcohol dependency

结局指标

主要结局

Duration of Untreated Psychosis measured with the NOS

时间窗: From start inclusion, marts 2024, to end inclusion marts 2027

PSP

时间窗: From beginning of 15 months follow-up, May 2025, until end of follow-up, September 2028

Personal and Social Performance Scale

次要结局

未报告次要终点

研究者

发起方
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nikolai Albert

Associate professor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

研究点 (2)

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