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Efficiency of a composite personalised care on functional outcome in early psychosis: A Prospective Randomised Controlled Trial
EU CTIS ID: 2025-520573-39-00
What this study is testing
To assess the efficacy of a composite personalised care (CPC) based on biological tests and clinical profile including (A) adaptation of add-on medications; (B) cognitive reinforcement using digital applications; or (A+B) their combination in patients with early psychosis, from baseline to 3 months, as compared as Treatment as usual (TAU) on global functioning measured by the Personal and Social Performance (PSP) Scale.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Adolescent and young adults, both sexes, aged 15 to 30 years,
- - Persons characterised according to the CAARMS criteria as UHR or FEP in the first two years after having received diagnosis and care, if any
- - Informed and written signed consent
- - Participant with regular health insurance (AME is not considered as a regular health insurance)
You likely can't join if
- Severe and unstabilised medical conditions
- Current daily use of substance of abuse other than nicotine and alcohol and higher than an average equivalent of 10 cannabis cigarettes AND/OR severe substance use disorder (DSMV criteria/dependence DSMIV criteria) other than nicotine during the last 12 months or for more than 5 years.
- Pregnant women, parturients, and lactating women
- Individuals deprived of their liberty by a judicial or administrative decision, persons under psychiatric care under articles L3212-1 and 3213-1 (Public Health Code)
- Individuals of legal age who are the subject of a legal protection measure or unable to express their consent
- Insufficient level in reading and/or French language,
See the full eligibility criteria
- - Adolescent and young adults, both sexes, aged 15 to 30 years,
- - Persons characterised according to the CAARMS criteria as UHR or FEP in the first two years after having received diagnosis and care, if any
- - Informed and written signed consent
- - Participant with regular health insurance (AME is not considered as a regular health insurance)
- Severe and unstabilised medical conditions
- Current daily use of substance of abuse other than nicotine and alcohol and higher than an average equivalent of 10 cannabis cigarettes AND/OR severe substance use disorder (DSMV criteria/dependence DSMIV criteria) other than nicotine during the last 12 months or for more than 5 years.
- Pregnant women, parturients, and lactating women
- Individuals deprived of their liberty by a judicial or administrative decision, persons under psychiatric care under articles L3212-1 and 3213-1 (Public Health Code)
- Individuals of legal age who are the subject of a legal protection measure or unable to express their consent
- Insufficient level in reading and/or French language,
- Current participation in another intervention trial or in a full cognitive remediation programme
- Enforced hospitalization (ASPDT, ASPPI, ASPRE)
- Intellectual Deficiency (i.e. IQ<70), and / or sensorimotor deficits incompatible with a cognitive reinforcement
- Former treated episode of psychosis, chronic schizophrenia, schizoaffective, or Bipolar disorder (preceeding the 24 months established in the inclusion criteria)
- Current severe depression (in case of doubt, MADRS > 34 criterium)
- Receiving therapeutic levels of antipsychotics for more than 24 months
- Current medication with benzodiazepine >30 mg per day equivalent diazepam
The study team makes the final eligibility decision.
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, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.