SchizophreniaOPUS-YOUNGNCT04916626
The OPUS YOUNG Trial. Early Intervention Versus Treatment as Usual for Adolescents With First-episode Psychosis
A study testing OPUS YOUNG and Treatment as Usual in people with Schizophrenia and Schizotypal Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Schizophrenia, Schizotypal Disorder, Delusional Disorder
- What is being tested?
- OPUS YOUNG and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteDenmark
- Study dates
- 6 May 2021to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Mental Health Services in the Capital Region, Denmark
Hellerup, 2900
About this study
Official title: The OPUS YOUNG Study. The Efficacy of Early Intervention Service Versus Treatment as Usual for Adolescents Aged 12 - 17 With First-episode Psychosis, a Pragmatic Randomized Clinical Trial
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.
Read the 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 hypothesis, that Early Intervention Services (EIS) is superior compared to standard care in the treatment of children and adolescents below age 18 years with first-episode psychosis. The hypothesis is based on extrapolation of research showing that EIS is superior to standard care in the treatment of adults with first-episode psychosis with regards to symptom reduction, function improvement, adherence to treatment, lower hospitalization risk, improved recovery, and higher cost-effectiveness. However, no trials have investigated EIS in samples of patients below age 18 years. We will compare the efficacy and cost-effectiveness of EIS to treatment as usual (TAU) in adolescents aged 12-17 years (both inclusive) with first-episode psychosis. We will build on a Danish evidence-based intervention developed for young adults (OPUS) and adjust the concept to meet the specific needs of children and adolescents with early onset psychosis (OPUS YOUNG). The OPUS treatment is a coordinated and integrated manualized multimodal treatment building on three core elements: modified assertive community treatment with a low patient-case manager ratio; psychoeducational family intervention; and social skills training (SST). In OPUS YOUNG we will adjust the OPUS program to fit our younger age group by: 1) intensifying the support for caretakers and relatives including siblings, 2) instead of SST we are introducing social cognition and interaction treatment (SCIT), 3) providing individual cognitive behavioural case management (CBCM) to all participants and cognitive behavioural therapy (CBT) when needed, 4) addressing the specific challenges of psychopharmacologic treatment in adolescents by providing a treatment algorithm, 5) providing intensive supported transition of care (when patients approach transition to adult mental health services), 6) providing individualized school support, and 7) providing integrated prevention and treatment of substance misuse. Based on sample size estimation, we will include a minimum of 284 participants (maximum 304) and randomize them 1:1 to a two-year intervention of OPUS YOUNG versus TAU. We will conduct blinded assessment of treatment effects after 12 months and at treatment endpoint at 24 months. A further follow-up assessment will be performed to evaluate the sustainability of the intervention effects at six months after transition from OPUS YOUNG to TAU. Our primary outcome at treatment endpoint will be social function measured with Personal and Social Performance Scale (PSP). Secondary key outcomes measures are positive and negative symptoms, client satisfaction, and health related quality of life. Further outcomes are the broader psychopathology, cognitive functioning, social cognition, self-efficacy, experience of service, treatment alliance and adherence, the use of pharmacotherapy, school adherence, family burden, siblings' perceived stress, substance misuse, adverse treatment effects, and health economic measures.
- Conditions
- Schizophrenia, Schizotypal Disorder, Delusional Disorder, Acute and Transient Psychotic Disorder, Unspecified, Schizoaffective Disorder, Non-Organic Psychosis
- Being tested
- OPUS YOUNG, Treatment as Usual
- Keywords
- Specialized early intervention, Early onset psychosis, Children and adolescents, Recovery and resilience, Cost-effectiveness, Cross-sectional
- Medical subject headings
- Schizophrenia, Schizotypal Personality Disorder, Schizophrenia, Paranoid, Psychotic Disorders, Mental Disorders, Psychoses, Substance-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPUS YOUNGBehavioural
OPUS YOUNG is a two year out-patient specialized early intervention service for children and adolescents with a first episode psychosis. The OPUS YOUNG treatment consists of the following elements: modified assertive community treatment, low patients to case manager ratio, cognitive-behavioural case management (CBCM), psycho-educational family treatment including multiple family groups(MFG) and psychoeducational siblings groups, Social Cognition and Interaction Training (SCIT), possible individual Cognitive Behavioural Therapy (CBT) in addition to CBCM, and manual based psychopharmacologic treatment. Additional, special transition support, individual school/employment support, and prevention and treatment of substance abuse.
Treatment as UsualBehavioural
The patients allocated to TAU will be offered non-manualized treatment following national Danish guidelines and local guidelines. Treatment is provided by a multidisciplinary team and consists of case-management (no defined upper case load), family support and psychoeducation, in addition to psychopharmacological treatment. In some cases, social skills training and CBT may be offered. In general, office visits take place in outpatient clinics.
| Study group | Role | What they receive |
|---|---|---|
| OPUS YOUNG | Experimental | OPUS YOUNG is a two years out-patients specialized early intervention services for children and adolescents with a first episode psychosis. OPUS YOUNG is characterized by a multidisciplinary team, assertive outreach, tailored cognitive behavioral case management, and low caseload and insensitive psychoeducational family involvement Receives: Behavioral: OPUS YOUNG |
| Treatment as Usual, TAU | Active comparator | Treatment as Usual will be carried out by outpatient clinic in Child and Adolescent Mental Health Services (CAMHS). Patients will be offered treatment following national Danish guidelines and local guidelines, provided by a multidisciplinary team, case-management (no defined upper-case load), family support. In general, office visits take place in outpatient clinics. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal and Social Performance Scale (PSP)
Change in the global score of social function, measured with Personal and Social Performance Scale (PSP). PSP provides a global score on a scale from 1-100, with lower scores indicating lower social functioning. The global score is based on scores on four subdomains (1. Socially useful activities, 2. Personal and social relationships, 3. Self-care, and 4. Disturbing and aggressive behaviour), rated on a 6-point Likert scale (1=absent to 6=very severe). The scoring of PSP is based on all available information and concerns the patient's daily level of functioning in the family, in school, and during leisure time during the past month. Higher global values mean better social function. Researchers will interview the participants prior to the scoring of PSP using a semi structured interview guide suitable for children and adolescents, developed by the OPUS YOUNG research team.
Measured: Last month at baseline (from enrollment), at month 12, at month 24 and at month 30
Secondary outcomes (5)
Severity of psychotic symptom dimension, SAPS
Scale for Assessing Psychotic Symptoms in Schizophrenia (SAPS), used to assess the phenomenological presentation of psychotic symptoms in schizophrenia, is a rating scale to measure positive symptoms in schizophrenia. The SAPS- scale is split into 4 sub-scales (hallucinations, delusions, bizarre behavior and formal thought disorder) each of which are rated from 0 (absent) to 5 (severe) and for each domain is also given a global symptom severity score by the rater. The Psychotic symptom dimension is the sum of global scores, divided by the number of global scores (range 0-5). The psychotic dimension is composed of scores of hallucination and delusions. Higher score indicates worse level of symptoms.
Measured: Last month at baseline (from enrollment), at month 12, at month 24 and at month 30
Severity of Negative symptom dimension, SANS
Scale for Assessing Negative Symptoms in Schizophrenia (SANS), used to assess the phenomenological presentation of negative symptoms in schizophrenia, is a rating scale to measure negative symptoms in schizophrenia. The SANS scale is divided into five sub-scales (affective flattening, alogia, avolition-apathy, anhedonia-asociality, attention), each of which are rated from 0 (absent) to 5 (severe) and for each domain is also given a global symptom severity score by the rater (global ratings). The Negative symptoms dimension is calculated as the sum of the global scores, divided by the number of global scores (range 0-5). The negative symptom dimension is composed of scores of anhedonia, avolition, affective flattening and alogia. Higher score indicates worse level of symptoms.
Measured: Last month at baseline (from enrollment), at month 12, at month 24 and at month 30
Severity of disorganized symptom dimension
Severity of Disorganized symptom dimension is calculated as the sum of the global scores of formal thought disorder, bizarre and behaviors from Scale for Assessing Psychotic Symptoms in Schizophrenia (SAPS) and the score of inappropriate affects (item within the subscale for affective flattening) in Scale for Assessing Negative Symptoms in Schizophrenia (SANS) (range 0-5).Higher score indicates worse level of symptoms.
Measured: Last month at baseline (from enrollment), at month 12, at month 24 and at month 30
Client satisfaction questionnaire, CSQ
Patients satisfaction with the treatment is measured with the CSQ-scale. CSQ assess global client satisfaction, along with single dimension. The CSQ has eight question-items (quality of service, kind of service, met needs, recommend to a friend, amount of help, deal with problems, overall satisfaction, and come back). Patients respond to those question-items using a 4-point Likert scale. Their responses are scored from 1 to 4, and thus the possible total scores range from 8 to 32. Higher scores indicate greater satisfaction. Self-rapport
Measured: Present time at month 12 and at month 24.
Quality of life, - Health Related Quality of Life Questionnaire for Children and Young People and their Parents, KIDSCREEN-10
The participants perception of their quality of life is assessed using the self-administered questionnaire KIDSCREEN-10. KIDSCREEN-10 contains 10 items: (1) Have you felt fit and well? (2) Have you felt full of energy? (3) Have you felt sad? (4) Have you felt lonely? (5) Have you had enough time for yourself? (6) Have you been able to do the things that you want to do in your free time? (7) Have your parent(s) treated you fairly? (8) Have you had fun with your friends? (9) Have you got on well at school? (10) Have you been able to pay attention? Participants respond to those question/items using a 5-point response scale. Answer categories item 1 and 9: not at all-slightly-moderately-very-extremely; all other items: never-seldom-quite often-very often-always. Responses are coded so that higher values indicate better QoL. A low score indicates a poor QOL, and a high score is indicative of a better QOL.
Measured: Last week at baseline (from enrollment), at month 12, at month 24 and at month 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start6 May 2021
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomized clinical trial is a parallel, two-arm, superiority trial comparing OPUS YOUNG with TAU for children and adolescents aged 12 - 17 years with a first episode psychosis
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Katrine Pagsberg, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Investigators
- Anne K Pagsberg, PhD, Principal investigator, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916626
- Sponsor's protocol ID
- OPUS YOUNG
- Acronym
- OPUS-YOUNG
- Status last verified
- Aug 2026
- First submitted
- 6 May 2021
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will share the depersonalized data at www.clinical Trials.gov
Publications
Madsen MS, Melau M, Andersen NK, Nielsen CF, Larsen N, Andersen TL, Nordentoft M, Jepsen JRM, Thorup AAE, Jeppesen P, Fagerlund B, Rimvall MK, McGorry P, Singh S, Vernal DL, Hastrup LH, Olsen LR, Rydkjaer J, Correll CU, Christensen R, Pagsberg AK. Early intervention versus treatment as usual for adolescents with first-episode psychosis: Protocol for the randomized OPUS YOUNG trial. Contemp Clin Trials. 2026 Mar;162:108253. doi: 10.1016/j.cct.2026.108253. Epub 2026 Feb 5.
PubMed 41654084
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The OPUS YOUNG Study. The Efficacy of Early Intervention Service Versus Treatment as Usual for Adolescents Aged 12 - 17 With First-episode Psychosis, a Pragmatic Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04916626
- Acronym / sponsor ID
- OPUS-YOUNG / OPUS YOUNG
- Conditions
- Schizophrenia, Schizotypal Disorder, Delusional Disorder, Acute and Transient Psychotic Disorder, Unspecified, Schizoaffective Disorder, Non-Organic Psychosis
- Keywords
- Specialized early intervention, Early onset psychosis, Children and adolescents, Recovery and resilience, Cost-effectiveness, Cross-sectional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 hypothesis, that Early Intervention Services (EIS) is superior compared to standard care in the treatment of children and adolescents below age 18 years with first-episode psychosis. The hypothesis is based on extrapolation of research showing that EIS is superior to standard care in the treatment of adults with first-episode psychosis with regards to symptom reduction, function improvement, adherence to treatment, lower hospitalization risk, improved recovery, and higher cost-effectiveness. However, no trials have investigated EIS in samples of patients below age 18 years. We will compare the efficacy and cost-effectiveness of EIS to treatment as usual (TAU) in adolescents aged 12-17 years (both inclusive) with first-episode psychosis. We will build on a Danish evidence-based intervention developed for young adults (OPUS) and adjust the concept to meet the specific needs of children and adolescents with early onset psychosis (OPUS YOUNG). The OPUS treatment is a coordinated and integrated manualized multimodal treatment building on three core elements: modified assertive community treatment with a low patient-case manager ratio; psychoeducational family intervention; and social skills training (SST). In OPUS YOUNG we will adjust the OPUS program to fit our younger age group by: 1) intensifying the support for caretakers and relatives including siblings, 2) instead of SST we are introducing social cognition and interaction treatment (SCIT), 3) providing individual cognitive behavioural case management (CBCM) to all participants and cognitive behavioural therapy (CBT) when needed, 4) addressing the specific challenges of psychopharmacologic treatment in adolescents by providing a treatment algorithm, 5) providing intensive supported transition of care (when patients approach transition to adult mental health services), 6) providing individualized school support, and 7) providing integrated prevention and treatment of substance misuse. Based on sample size estimation, we will include a minimum of 284 participants (maximum 304) and randomize them 1:1 to a two-year intervention of OPUS YOUNG versus TAU. We will conduct blinded assessment of treatment effects after 12 months and at treatment endpoint at 24 months. A further follow-up assessment will be performed to evaluate the sustainability of the intervention effects at six months after transition from OPUS YOUNG to TAU. Our primary outcome at treatment endpoint will be social function measured with Personal and Social Performance Scale (PSP). Secondary key outcomes measures are positive and negative symptoms, client satisfaction, and health related quality of life. Further outcomes are the broader psychopathology, cognitive functioning, social cognition, self-efficacy, experience of service, treatment alliance and adherence, the use of pharmacotherapy, school adherence, family burden, siblings' perceived stress, substance misuse, adverse treatment effects, and health economic measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The randomized clinical trial is a parallel, two-arm, superiority trial comparing OPUS YOUNG with TAU for children and adolescents aged 12 - 17 years with a first episode psychosis
| Arm | Type | Receives |
|---|---|---|
| OPUS YOUNG | Experimental | Behavioral: OPUS YOUNGOPUS YOUNG is a two years out-patients specialized early intervention services for children and adolescents with a first episode psychosis. OPUS YOUNG is characterized by a multidisciplinary team, assertive outreach, tailored cognitive behavioral case management, and low caseload and insensitive psychoeducational family involvement |
| Treatment as Usual, TAU | Active comparator | Behavioral: Treatment as UsualTreatment as Usual will be carried out by outpatient clinic in Child and Adolescent Mental Health Services (CAMHS). Patients will be offered treatment following national Danish guidelines and local guidelines, provided by a multidisciplinary team, case-management (no defined upper-case load), family support. In general, office visits take place in outpatient clinics. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPUS YOUNGOPUS YOUNG is a two year out-patient specialized early intervention service for children and adolescents with a first episode psychosis. The OPUS YOUNG treatment consists of the following elements: modified assertive community treatment, low patients to case manager ratio, cognitive-behavioural case management (CBCM), psycho-educational family treatment including multiple family groups(MFG) and psychoeducational siblings groups, Social Cognition and Interaction Training (SCIT), possible individual Cognitive Behavioural Therapy (CBT) in addition to CBCM, and manual based psychopharmacologic treatment. Additional, special transition support, individual school/employment support, and prevention and treatment of substance abuse. | Behavioural | OPUS YOUNG |
| Treatment as UsualThe patients allocated to TAU will be offered non-manualized treatment following national Danish guidelines and local guidelines. Treatment is provided by a multidisciplinary team and consists of case-management (no defined upper case load), family support and psychoeducation, in addition to psychopharmacological treatment. In some cases, social skills training and CBT may be offered. In general, office visits take place in outpatient clinics. | Behavioural | Treatment as Usual, TAU |
Primary outcome
Personal and Social Performance Scale (PSP)
Time frame: Last month at baseline (from enrollment), at month 12, at month 24 and at month 30
Change in the global score of social function, measured with Personal and Social Performance Scale (PSP). PSP provides a global score on a scale from 1-100, with lower scores indicating lower social functioning. The global score is based on scores on four subdomains (1. Socially useful activities, 2. Personal and social relationships, 3. Self-care, and 4. Disturbing and aggressive behaviour), rated on a 6-point Likert scale (1=absent to 6=very severe). The scoring of PSP is based on all available information and concerns the patient's daily level of functioning in the family, in school, and during leisure time during the past month. Higher global values mean better social function. Researchers will interview the participants prior to the scoring of PSP using a semi structured interview guide suitable for children and adolescents, developed by the OPUS YOUNG research team.
5 secondary outcomes
Severity of psychotic symptom dimension, SAPS
Time frame: Last month at baseline (from enrollment), at month 12, at month 24 and at month 30
Severity of Negative symptom dimension, SANS
Time frame: Last month at baseline (from enrollment), at month 12, at month 24 and at month 30
Severity of disorganized symptom dimension
Time frame: Last month at baseline (from enrollment), at month 12, at month 24 and at month 30
Client satisfaction questionnaire, CSQ
Time frame: Present time at month 12 and at month 24.
Quality of life, - Health Related Quality of Life Questionnaire for Children and Young People and their Parents, KIDSCREEN-10
Time frame: Last week at baseline (from enrollment), at month 12, at month 24 and at month 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 41654084Madsen MS, Melau M, Andersen NK, Nielsen CF, Larsen N, Andersen TL, Nordentoft M, Jepsen JRM, Thorup AAE, Jeppesen P, Fagerlund B, Rimvall MK, McGorry P, Singh S, Vernal DL, Hastrup LH, Olsen LR, Rydkjaer J, Correll CU, Christensen R, Pagsberg AK. Early intervention versus treatment as usual for adolescents with first-episode psychosis: Protocol for the randomized OPUS YOUNG trial. Contemp Clin Trials. 2026 Mar;162:108253. doi: 10.1016/j.cct.2026.108253. Epub 2026 Feb 5.
- Individual participant dataSharing planned: No. The investigators will share the depersonalized data at www.clinical Trials.gov
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne K Pagsberg, PhD principal investigator
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPUS YOUNG and Treatment as Usual in people with Schizophrenia and Schizotypal Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal and Social Performance Scale (PSP) (time frame: Last month at baseline (from enrollment), at month 12, at month 24 and at month 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04916626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.