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

NCT07716969 | Recruiting

• 1 other identifier: H-23040813
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Psychosis; Schizo Affective Disorder; SCHIZOPHRENIA 1 (Disorder)

Keywords

Duration of Untreated Psychosis; Early Detection; Psychosis; Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Duration of Untreated Psychosis measured with the NOS

  From start inclusion, marts 2024, to end inclusion marts 2027

• PSP

  Personal and Social Performance Scale

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

Study Arms (2)

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

Other: No intervention (Observational Study)

Cohort 2: Capital Region Usual-Detection Cohort

Cohort 2: Capital Region Usual-Detection Cohort

Other: No intervention (Observational Study)

Interventions

No intervention (Observational Study) OTHER

Participants receive standard clinical care independent of the study. No intervention is assigned by investigators.

Cohort 1: Region Zealand Early-Detection Cohort; Cohort 2: Capital Region Usual-Detection Cohort

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• The Novo Nordic Foundation: collaborator

Study Sites (2)

Mental Health Centre Copenhagen

Copenhagen, Denmark, 2900, Denmark

RECRUITING

Region Zealand Psychiatry East

Roskilde, Denmark, 4000, Denmark

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Interventions

Observation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Nikolai Albert

  Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolai Albert, MD, PhD

CONTACT

+45 29925014; nikolai.albert@regionh.dk

Stephen F Austen, PhD

CONTACT

+45 23259577; stfa@regionsjaelland.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 01.01.2030, no end data
• Access Criteria: The National archives will make decision based on national data protection laws.

Locations

DK (2)