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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: f
View:

• 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.

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Locations
Other Locations
Denmark
Mental Health Centre Copenhagen
RECRUITING
Copenhagen
Region Zealand Psychiatry East
RECRUITING
Roskilde
Contact Information
Primary
Nikolai Albert, MD, PhD
nikolai.albert@regionh.dk
+45 29925014
Backup
Stephen F Austen, PhD
stfa@regionsjaelland.dk
+45 23259577
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 250
Treatments
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
Cohort 2: Capital Region Usual-Detection Cohort
Cohort 2: Capital Region Usual-Detection Cohort
Related Therapeutic Areas
Sponsors
Collaborators: The Novo Nordic Foundation
Leads: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

This content was sourced from clinicaltrials.gov