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New treatment option for Psychosis
Official title Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis
ClinicalTrials.gov ID: NCT05796401
What this study is testing
What is Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC?
Personalized neuroprotective strategies : Vitamin B12, folinic acid, Omega 3, NAC is an investigational medicine, being studied as a potential treatment for psychosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Chronic psychosis, including schizophrenia is now viewed as a progressive disorder where cognitive deficits predate the clinical onset. Early intervention programs improve the general outcome with staged care strategies, supporting the view that the period before and around the first episode of psychosis is a window of opportunity for improving its functional recovery.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 30
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 [8] as UHR or FEP in the first year after having received diagnosis and care, if any
- Informed and written signed consent,
- Participant with regular health insurance
You likely can't join if
- Severe and unstabilised medical conditions,
- Insufficient level in reading and/or French language,
- Current participation in another intervention trial or in a full cognitive remediation programme,
- Enforced hospitalization ,
- Intellectual Deficiency (i.e. Intelligence Quotient\<70), and / or sensorimotor deficits incompatible with the cognitive reinforcement,
- Former treated episode of psychosis, chronic schizophrenia, schizoaffective, or Bipolar disorder (preceeding the 12 months established in the...
See the full eligibility criteria
- Adolescent and young adults, both sexes, aged 15 to 30 years,
- Persons characterised according to the CAARMS criteria [8] as UHR or FEP in the first year after having received diagnosis and care, if any
- Informed and written signed consent,
- Participant with regular health insurance
- Severe and unstabilised medical conditions,
- Insufficient level in reading and/or French language,
- Current participation in another intervention trial or in a full cognitive remediation programme,
- Enforced hospitalization ,
- Intellectual Deficiency (i.e. Intelligence Quotient\<70), and / or sensorimotor deficits incompatible with the cognitive reinforcement,
- Former treated episode of psychosis, chronic schizophrenia, schizoaffective, or Bipolar disorder (preceeding the 12 months established in the inclusion criteria),
- Current severe depression (in case of doubt, MADRS \> 34),
- Receiving therapeutic levels of antipsychotics for more than 12 months,
- Current medication with benzodiazepine \>30 mg per day equivalent diazepam
- Current daily use of substance of abuse other than nicotine and alcohol and higher than an average equivalent of 5 cannabis cigarettes AND/OR severe substance use disorder (DSMV criteria/dependence DSMIV criteria) other...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brest, France
- Caen, France
- Clermont-Ferrand, France
- Dijon, France
- Lille, France
- Montpellier, France
- Nancy, France
- Orsay, France
- Paris, France
- Poitiers, France
- Rennes, France
- Toulouse, 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, 15 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brest, France; Caen, France; Clermont-Ferrand, France; Dijon, France; Lille, France; Montpellier, France and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.