Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a tailored youth program turn the tide on early psychosis?

NCT ID NCT04916626

Disease control Sponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether a specialized two-year early intervention service, called OPUS YOUNG, can improve daily and social functioning in adolescents aged 12-17 who have experienced a first episode of psychosis. Participants are randomly assigned to either OPUS YOUNG or standard treatment. The program includes intensive case management, family support, social cognition training, and individual therapy, aiming to address the unique needs of young people. The study measures functioning, symptoms, quality of life, and school or work engagement after 24 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OPUS YOUNG, a two-year specialized early intervention service combining assertive community treatment, cognitive-behavioural case management, family psychoeducation, social cognition training, and individual CBT
What this could lead to
If effective, this approach could reduce the long-term disability and burden of early-onset psychosis, improving social functioning and quality of life for adolescents.
What could go wrong
The trial is still in progress, and results may not show a clear benefit over usual care. The intervention is complex and resource-intensive, which may limit implementation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

284 people

The number who actually took part.

Started

May 2021

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Between 12 and 17 years of age (both inclusive) at trial inclusion. 2. 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). 3. Maximum 12 months since first prescription of antipsychotic treatment on the indication psychosis. 4. Speak and understand Danish. 5. 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: 1. 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). 2. Currently compulsory admission and/or treatment according to Danish legislation

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute and transient psychotic disorder, unspecified are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

delusional disorder depressive disorder drug psychosis major depressive disorder paranoid schizophrenia psychiatric disorder Psychotic Disorders schizoaffective disorder schizophrenia schizotypal personality disorder substance-induced psychosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute and transient psychotic disorder, unspecified Delusional disorder Depression severe Non-organic psychosis Schizoaffective disorder Schizophrenia Schizotypal disorder Substance induced psychoses

Contacts and locations

Locations

  • Mental Health Services in the Capital Region, Denmark

    Hellerup, 2900, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.