The OPUS YOUNG Trial. Early Intervention Versus Treatment as Usual for Adolescents With First-episode Psychosis

  • End date
    Sep 8, 2025
  • participants needed
  • sponsor
    Mental Health Services in the Capital Region, Denmark
Updated on 8 September 2021
behavioral therapy
schizoaffective disorder
of substance abuse
psychotic symptoms
delusional disorder


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 284 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.

Condition Depression Severe, Schizotypal Personality Disorder (SPD), schizophrenia disorders, schizotypal disorder, Schizophrenia, Drug use, Schizophrenia and Schizoaffective Disorders, Acute and Transient Psychotic Disorder, Unspecified, Poisoning, Schizotypal Personality Disorder, Severe Depression, Drug-induced psychosis, Non-Organic Psychosis, Drug abuse, Paranoid Schizophrenia, schizoaffective disorder, Schizophrenia and Schizoaffective Disorders (Pediatric), Sun Poisoning, Psychosis, delusional disorder, Substance Abuse
Treatment Treatment As Usual, OPUS YOUNG
Clinical Study IdentifierNCT04916626
SponsorMental Health Services in the Capital Region, Denmark
Last Modified on8 September 2021


Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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