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TOPUS - Testing an Implemented Intervention to Reduce Duration of Untreated Psychosis (TOPUS)

2026년 7월 16일 업데이트: Nikolai Albert, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

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

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

Study Design

The project uses a quasi-experimental design with two non-overlapping recruitment areas. Participants are adults with a first diagnosis of a schizophrenia-spectrum disorder who have entered OPUS treatment in either Region Zealand (early-detection region) or the Capital Region (comparison region). No experimental intervention is delivered by the research team. All participants receive routine clinical care as determined by their local OPUS center. The research activities consist of structured assessments conducted at baseline and during follow-up.

Because patients are recruited within established treatment programs and no treatment allocation is made, the study does not involve randomization or modification of clinical care. The design instead tests whether an existing system-level initiative-public awareness campaigns, stakeholder outreach, and a specialized early-detection team-has produced measurable differences in DUP and outcomes.

Study Objectives

The project is organized around three central objectives:

Effectiveness of Early Detection (WQ1):

Determine whether the early-detection initiatives in Region Zealand reduce DUP in first-episode schizophrenia compared with the Capital Region.

Impact of DUP on Outcomes (WQ2):

Evaluate whether variation in DUP predicts fifteen months functional and psychopathological outcomes within the cohort.

Operationalization of DUP (WQ3):

Compare different definitions and measurement approaches to identify how DUP is most reliably assessed and how different operationalizations affect its predictive power.

Assessments and Data Collection

At baseline, participants complete structured clinical interviews and psychometric assessments focusing on psychopathology, functioning, premorbid adjustment, cognition, and pathways to care. The measurement of DUP is central: the study uses the Nottingham Onset Schedule (NOS) as the primary tool, and definitions distinguishing between patient-level delay ("DUP Demand"), system-level delay ("DUP Supply"), and total DUP.

To examine trajectories after treatment begins, participants are contacted at 3 and 9 months for focused follow-up assessments, and they undergo a comprehensive fifteen months evaluation of functioning, symptoms, cognition, suicidality, and treatment factors. Register-based data on education, employment, hospitalization, and family formation supplement missing or incomplete follow-up information.

Analytical Approach

Because DUP is typically skewed, analyses will apply appropriate transformations or non-parametric approaches. Comparisons between regions will adjust for relevant confounders. Functional and symptom outcomes will be evaluated using regression models, and trajectories across the fifteen month period will be explored using latent class growth analysis to identify distinct functional subgroups. Multiple imputation will be used for handling missing follow-up data.

Expected Contributions

This study is among the few to evaluate early-detection efforts under real-world conditions in a public mental-health system. By comparing two regions with stable, well-defined differences in detection practices but identical treatment programs, the design provides an opportunity to examine both the system-level impact on DUP and the clinical implications of altered detection timing.

The results are expected to address three major uncertainties in the field:

whether early-detection campaigns and outreach teams meaningfully reduce the time patients remain untreated,

whether a reduced DUP improves functional and clinical outcomes, and

how DUP should be operationalized to provide the clearest and most clinically relevant information.

Establishing the effectiveness of an already-implemented early-detection model has the potential to inform service planning in Denmark and internationally. In addition, clarifying the causal role of DUP could support future health-care strategies aimed at minimizing untreated psychosis, and the project's methodological work may contribute to consensus definitions for DUP in both clinical and research settings.

연구 유형

관찰

등록 (추정된)

250

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Denmark
      • Copenhagen, Denmark, 덴마크, 2900
        • 모병
        • Mental Health Centre Copenhagen
        • 연락하다:
        • 수석 연구원:
          • Nikolai Albert, MD, PhD
        • 연락하다:
      • Roskilde, Denmark, 덴마크, 4000
        • 모병
        • Region Zealand Psychiatry East
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Stephen f Austin, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

Patients are recruted within the first 9 months of their OPUS treatment in the Capital region or Region Zealand.

설명

Inclusion Criteria:

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.

-

Exclusion Criteria:

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Cohort 1: Region Zealand Early-Detection Cohort
Participants identified through in a region with a early-detection program, which could identify participants prior to OPUS treatment
Participants receive standard clinical care independent of the study. No intervention is assigned by investigators.
Cohort 2: Capital Region Usual-Detection Cohort
Participants receive standard clinical care independent of the study. No intervention is assigned by investigators.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Duration of Untreated Psychosis measured with the NOS
기간: From start inclusion, marts 2024, to end inclusion marts 2027
From start inclusion, marts 2024, to end inclusion marts 2027
PSP
기간: From beginning of 15 months follow-up, May 2025, until end of follow-up, September 2028
Personal and Social Performance Scale
From beginning of 15 months follow-up, May 2025, until end of follow-up, September 2028

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Nikolai Albert, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 3월 1일

기본 완료 (추정된)

2026년 12월 31일

연구 완료 (추정된)

2028년 7월 31일

연구 등록 날짜

최초 제출

2026년 7월 16일

QC 기준을 충족하는 최초 제출

2026년 7월 16일

처음 게시됨 (실제)

2026년 7월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 16일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • H-23040813

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Data will after completion of the study be transferred in the Danish National Archives, where from they can be requested and delivered in accordance with Danish data protection laws.

IPD 공유 기간

01.01.2030, no end data

IPD 공유 액세스 기준

The National archives will make decision based on national data protection laws.

IPD 공유 지원 정보 유형

  • 연구_프로토콜

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .