Personalized support after first psychosis: a 3-Year test
NCT ID NCT05116514
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether regular, personalized follow-up by a trained case manager can reduce the chance of another psychotic episode over three years in people aged 16 to 30 who have just had their first episode. 256 participants will be randomly assigned to either standard care or case management. The goal is to see if this approach can be rolled out widely to improve recovery and prevent relapse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- case management (regular personalized follow-up by a trained case manager)
- What this could lead to
- If it works, this could provide a scalable way to improve long-term outcomes for young people after a first psychotic episode, reducing relapse and hospitalizations.
- What could go wrong
- This is an open-label study, so both patients and staff know who gets the intervention, which can bias results. It is also relatively small (256 people) and focuses on a specific age group, so findings may not apply to everyone.
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
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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
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About 256 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2021
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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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
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16 to 30 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * The patient or their close relative must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan * The patient is available for a 3-year follow-up. * Patient is managed in a psychiatric service (consultation or hospitalization) for a first episode psychosis defined by: * Presence of positive psychotic symptoms (delusion(s) and/or hallucination(s) and/or conceptual disorganization) evolving for at least one week, either daily or at least 3 times per week for at least one hour per occasion ; * Never having taken a neuroleptic treatment with antipsychotic aim (except for an antipsychotic treatment started for the current episode for example by the general practitioner before being referred to psychiatry); * A disorder meeting the DSM 5 criteria from the following list: delusional disorder, brief psychotic disorder greater than 7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder greater than 7 days, other specific or nonspecific schizophrenic spectrum disorder or other psychotic disorder, bipolar I or II disorder with congruent and non-mood congruent psychotic features, bipolar disorder with congruent and non-mood congruent psychotic features induced by a substance, major depressive disorder with congruent and non-mood congruent psychotic features. * Inclusion should be within the first 3 months of care for first episode psychosis in the psychiatric service. * At the time of inclusion, the psychotic symptomatology observed during the first episode psychosis may still be present or in remission. Exclusion Criteria: * The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study * The subject, or one of the parents for minor patients, refuses to sign the consent * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship * The patients has an IQ less than or equal to 55 * The patient has a first psychotic episode linked to a psychotic problem triggered by a medication of other medical condition * The patient is pregnant or breastfeeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CH Saint Marie Clermont-Ferrand
NOT_YET_RECRUITINGClermont-Ferrand, France
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CHU Nice
NOT_YET_RECRUITINGNice, France
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CHU de Montpellier
RECRUITINGMontpellier, France
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CHU de Nîmes
RECRUITINGNîmes, France
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CHU de TOULOUSE
NOT_YET_RECRUITINGToulouse, Choisir Une Région, 31, France
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Centre Hospitalier Léon-Jean Grégory
RECRUITINGThuir, France
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