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Delusional Disorder / OPUS YOUNG / Schizophrenia · Interventional Study
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed but unpublished pragmatic RCT comparing a 2-year specialized early intervention service (OPUS YOUNG) versus treatment as usual for adolescents aged 12–17 with first-episode psychosis in Denmark. The trial is registered with a blinded design and a hard clinical outcome (personal and social functioning at 24 months), but no efficacy data have been posted in this registry record, so the direction, magnitude, or significance of any effect remains unknown.
Interventional, Randomized, Parallel, Double masking, Treatment purpose. Schizophrenia, Schizotypal Disorder, Delusional Disorder, Acute and Transient Psychotic Disorder, Unspecified, Schizoaffective Disorder, Non-Organic Psychosis,…; age from 12 Years; to 17 Years. Intervention: OPUS YOUNG. Compared with: Treatment as Usual, TAU — Active Comparator. n = 284. 1 site: Denmark.
This is a completed but unpublished pragmatic RCT comparing a 2-year specialized early intervention service (OPUS YOUNG) versus treatment as usual for adolescents aged 12–17 with first-episode psychosis in Denmark. The trial is registered with a blinded design and a hard clinical outcome (personal and social functioning at 24 months), but no efficacy data have been posted in this registry record, so the direction, magnitude, or significance of any effect remains unknown.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
If results become available, this trial will directly inform whether specialized early intervention improves functioning in youth-onset psychosis compared to standard care. The pragmatic design and blinded outcome assessment enhance clinical relevance, but efficacy remains unproven pending publication.
This is a completed trial registry record with no posted results; the planned design is sound (pragmatic RCT, blinded outcomes) but efficacy remains unreported and unknown.
As stated by the source record.
Quoted from the source exactly as published.
If results become available, this trial will directly inform whether specialized early intervention improves functioning in youth-onset psychosis compared to standard care. The pragmatic design and blinded outcome assessment enhance clinical relevance, but efficacy remains unproven pending publication.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04916626). This is a study registration, not published results. Lead sponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 284 participants (ACTUAL). Conditions: Schizophrenia, Schizotypal Disorder, Delusional Disorder, Acute and Transient Psychotic Disorder, Unspecified, Schizoaffective Disorder, Non-Organic Psychosis, Depression Severe, Substance Induced Psychoses. Interventions: BEHAVIORAL: OPUS YOUNG; BEHAVIORAL: Treatment as Usual. Primary outcome measures: Personal and Social Performance Scale (PSP) , Last month at baseline (from enrollment), at month 12, at month 24 and at month 30. 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 yearly incidence of schizophrenia in youth below the age of 18 years has increased from 137 in 2000 to 477 in 2016. Outcomes in people with schizophrenia spectrum disorders are suboptimal with low quality of life, low rates of recovery, substance misuse, higher rates of suicide, violence and legal problems, low educational and vocational attainment, and a significantly reduced life-expectancy of 15-20 year. Schizophrenia imply a large burden of disease with severe impact on patients, their families, the service system and a large economic societal burden. The investigators will include 290 participants age 12-17 years with an early onset psychosis within the following diagnostic classes: schizophrenia spectrum, psychotic depression or drug-induced psychosis. The design is an independent, investigator initiated, pragmatic, randomized clinical trial, with blinded outcome assessment. Participants are randomized 1:1 to OY or TAU. Participants in OY are offered 2 years of specialized intervention (OY) regardless of age, while participants in TAU are switched to adult psychiatry at the age of 18 years. OY builds on the Danish evidenced based intervention for young adults, OPUS, adjusted to meet the specific needs of adolescents: intensified support for caretakers and relatives including siblings; social cognition and interaction treatment; and individual cognitive behavioral case management. OY addresses the specific challenges of psychopharmacologic treatment in youth; supported transition to adult care after OY; school or educational support; and prevention and treatment of substance misuse. The primary endpoint is improved functioning in daily and social life after 24 months. Secondary outcome measures are psychopathology, quality of life, family stress, and retention in treatment and school/employment, and healthcare consumption. The clinical and societal perspective of a large scale implementation is improved prevention of the negative consequences of early-onset psychosis and a reduced burden of severe mental illness.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.