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Study on the Effectiveness of Calcium Folinate, Omega-3-Acid Ethyl Esters, and Cyanocobalamin for Patients at High Risk of Psychosis or Experiencing First Episode Psychosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a personalized care approach for individuals experiencing early psychosis, which includes those at an Ultra High Risk of psychosis and those having a first episode of psychosis. The study aims to evaluate how well this personalized care improves daily functioning compared to the usual treatment. The personalized care involves adjusting additional medications and using digital tools to enhance cognitive abilities, either separately or together.

The trial will use several medications, including Folinoral (containing calcium folinate), Omacor (containing omega-3-acid ethyl esters 90), Vitamine B12 Gerda (containing cyanocobalamin), and Mucodrill (containing acetylcysteine). These medications will be administered over a period of up to 12 weeks. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual medications.

The study will monitor participants' progress from the start to three months later, using a tool called the Personal and Social Performance (PSP) Scale to measure improvements in their ability to function in daily life. This trial is designed to provide insights into how personalized care can benefit those with early psychosis, potentially leading to better treatment strategies in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to evaluate the current health status and eligibility based on specific criteria.
This assessment includes a review of medical history and a series of tests to establish a baseline for the trial.
Step 2
Medication administration
Participants receive a combination of medications designed to support their treatment. These include:
Folinoral 25 mg, a hard capsule containing calcium folinate, taken by placing it in the mouth to dissolve.
Omacor 1000 mg, a soft capsule containing omega-3-acid ethyl esters 90, also taken by placing it in the mouth to dissolve.
Vitamine B12 Gerda 250 micrograms, a tablet containing cyanocobalamin, taken by placing it in the mouth to dissolve.
Mucodrill 600 mg, an effervescent tablet containing acetylcysteine, taken by placing it in the mouth to dissolve.
Step 3
Cognitive reinforcement
Participants engage in cognitive reinforcement activities using digital applications. These activities are designed to enhance cognitive function and support overall treatment goals.
Step 4
Combination therapy
Some participants may receive a combination of medication and cognitive reinforcement, depending on their individual needs and clinical profile.
Step 5
Monitoring and evaluation
Throughout the trial, participants are regularly monitored to assess their progress and response to treatment.
The primary measure of success is the improvement in global functioning, evaluated using the Personal and Social Performance (PSP) Scale.
Step 6
Conclusion of trial
The trial concludes 3 to 4 months after the start, with a final assessment to determine the overall effectiveness of the treatment.
Results are compared to standard treatment practices to evaluate the benefits of the composite personalised care approach.

Who can join the trial?

4 criteria

Adolescents and young adults, both males and females, aged 15 to 30 years.
Individuals identified as having an **Ultra High Risk (UHR)** of psychosis or experiencing a **First Episode Psychosis (FEP)** within the first year after diagnosis and care, if any. **Psychosis** is a condition that affects the mind, causing a person to lose touch with reality.
Must provide informed and written signed consent, meaning they understand the study and agree to participate.
Participants must have regular health insurance. **AME** (a specific type of health coverage) is not considered regular health insurance.

Who cannot join the trial?

5 criteria

Patients who are not at an ultra high risk of psychosis or do not have a first episode of psychosis cannot participate. Psychosis is a condition that affects the mind, where there is some loss of contact with reality.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not willing to use digital applications for cognitive reinforcement cannot participate. Cognitive reinforcement involves activities that help improve thinking and understanding.
Patients who are not able to adapt to changes in their medication as part of the study cannot participate. This means being open to adjustments in their current treatment plan.
Patients who are part of a vulnerable population, such as those who cannot give informed consent, cannot participate. Informed consent means understanding the study and agreeing to take part.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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CHU Grenoble Alpes
La Tronche, France
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Centre Hospitalier Regional Et Universitaire De Brest
Brest, France
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Centre Hospitalier Universitaire De Caen Normandie
Caen, France

Trial locations

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Investigated drugs

Composite Personalised Care (CPC)
is a tailored treatment approach designed for patients with early psychosis. It involves using biological tests and clinical profiles to adapt additional medications and enhance cognitive abilities through digital applications. This personalized care aims to improve the overall functioning of patients by addressing their specific needs.
Treatment as Usual (TAU)
refers to the standard care that patients with early psychosis typically receive. This may include regular medication, therapy sessions, and other conventional treatments that are generally provided in clinical settings. The trial compares the effectiveness of the Composite Personalised Care against this standard treatment.

What is already known about the treatment

Composite Personalised Care (CPC) – This approach is not a single medication but a treatment strategy that combines biological tests and clinical profiling to tailor care for individuals with early psychosis. It involves the adaptation of additional medications and cognitive reinforcement through digital applications, either separately or in combination. The current status in medical literature is as part of a clinical trial aimed at improving functional outcomes in early psychosis. The main therapeutic indication is for individuals at ultra-high risk of psychosis or experiencing their first episode. The mechanism of action involves personalized adjustments to treatment plans based on individual biological and clinical data, enhancing the effectiveness of standard care. This strategy falls under the category of personalized medicine, focusing on optimizing treatment for better personal and social performance.

Investigated diseases

Ultra High Risk of Psychosis
This condition refers to individuals who are at a significantly increased risk of developing psychosis. It is characterized by subtle changes in thoughts, perceptions, and behaviors that are not yet severe enough to meet the criteria for a full-blown psychotic disorder. People in this stage may experience unusual thoughts, heightened sensitivity to sensory stimuli, or mild perceptual disturbances. The progression can vary, with some individuals developing a psychotic disorder, while others may not progress further. Early intervention is often considered crucial to potentially alter the course of the condition.
First Episode Psychosis
This term describes the initial occurrence of psychotic symptoms in an individual. Symptoms may include hallucinations, delusions, disorganized thinking, and impaired insight. The onset is often sudden and can be distressing for both the individual and their family. The progression of first episode psychosis can vary, with some individuals experiencing a single episode and others having recurrent episodes. Early treatment is often emphasized to help manage symptoms and improve long-term outcomes.