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

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

250

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Denmark
      • Copenhagen, Denmark, Danimarca, 2900
        • Reclutamento
        • Mental Health Centre Copenhagen
        • Contatto:
        • Investigatore principale:
          • Nikolai Albert, MD, PhD
        • Contatto:
      • Roskilde, Denmark, Danimarca, 4000
        • Reclutamento
        • Region Zealand Psychiatry East
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Stephen f Austin, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Duration of Untreated Psychosis measured with the NOS
Lasso di tempo: From start inclusion, marts 2024, to end inclusion marts 2027
From start inclusion, marts 2024, to end inclusion marts 2027
PSP
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Nikolai Albert, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 marzo 2024

Completamento primario (Stimato)

31 dicembre 2026

Completamento dello studio (Stimato)

31 luglio 2028

Date di iscrizione allo studio

Primo inviato

16 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

16 luglio 2026

Primo Inserito (Effettivo)

21 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

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.

Periodo di condivisione IPD

01.01.2030, no end data

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su No intervention (Observational Study)

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