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New treatment option for Psychotic Episode
Official title Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode.
ClinicalTrials.gov ID: NCT05116514
What this study is testing
- What it's testing
- The study investigators hypothesize that the intervention of case managers specifically trained in case management of early psychosis will change the paradigm of care of a first psychotic episode from the current organization of the care system. Indeed, the creation of specific services for emerging psychotic disorders cannot easily be generalized throughout the country and requires specific funding.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 30
You may be able to join if
- 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...
You likely can't join if
- The subject is participating in another category I treatment 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
See the full eligibility 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...
- 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...
- 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.
- The subject is participating in another category I treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Toulouse, Choisir Une Région, France
- Clermont-Ferrand, France
- Montpellier, France
- Nice, France
- Nîmes, France
- Thuir, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toulouse, Choisir Une Région, France; Clermont-Ferrand, France; Montpellier, France; Nice, France; Nîmes, France; Thuir, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.