Status:
ACTIVE_NOT_RECRUITING
The OPUS YOUNG Trial. Early Intervention Versus Treatment as Usual for Adolescents With First-episode Psychosis
Lead Sponsor:
Mental Health Services in the Capital Region, Denmark
Conditions:
Schizophrenia
Schizotypal Disorder
Eligibility:
All Genders
12-17 years
Phase:
NA
Brief Summary
The OPUS YOUNG (OY) study investigates the efficacy of early intervention service versus treatment as usual (TAU) for adolescents aged 12-17 years with a first-episode psychosis. In Denmark, the year...
Detailed Description
The overarching purpose of the OPUS YOUNG trial is to improve the treatment and outcome of first-episode psychosis (FEP) in children and adolescents. We will address this ambition by testing the hypot...
Eligibility Criteria
Inclusion
- Between 12 and 17 years of age (both inclusive) at trial inclusion.
- First-episode psychosis within F2 spectrum (F20 schizophrenia, F21 Schizotypal disorder, F22 delusional disorder, F23 acute and transient psychotic disorders, F25 schizoaffective disorders, F28/29 other or un-specified non-organic psychosis) or depression with psychotic symptoms (F32.3, F33.3) or substance-induced psychosis (F1X.5) according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10).
- Maximum 12 months since first prescription of antipsychotic treatment on the indication psychosis.
- Speak and understand Danish.
- Written informed consent from parents or legal caretakers. Participants who reach age 18 years during the trial will be asked to give personal written informed consent to continue their study participation.
Exclusion
- A diagnosis of mental retardation of at least moderate severity defined as an intelligence quotient (IQ)of 49 or below (F71, F72, F73 according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10).
- Currently compulsory admission and/or treatment according to Danish legislation
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT04916626
Start Date
May 6 2021
End Date
March 1 2026
Last Update
February 12 2025
Active Locations (1)
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1
Mental Health Services in the Capital Region, Denmark
Hellerup, Denmark, 2900