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NCT07716969Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 21 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
250 (estimated)
First submitted
16 Jul 2026
Start date
1 Mar 2024
Primary completion date
31 Dec 2026
Lead sponsor
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
NCT number
NCT07716969

What you commit to

  • Study type: Observational
  • Planned participants: 250
  • From 1 Mar 2024 to the primary completion date, 31 Dec 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Who the study is looking for

  • 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.
  • \-

Age in the registry: 18 years to 35 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mental Health Centre Copenhagen
Coordinator of this site? Confirm its status
CopenhagenDenmarkRecruiting
Region Zealand Psychiatry East
Coordinator of this site? Confirm its status
RoskildeDenmarkRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.