Identifying first-episode psychosis patients who do not respond to first-line treatment

Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies: A Multicentric Study

This project will try to see if MRI brain markers and machine-learning methods can predict which people aged 18–35 with a first episode of psychosis will not have symptom remission after three months.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years to 35 Years
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Academic / other)
• Locations: 5 sites (Bron and 4 other locations)
• Trial ID: NCT02670447 on ClinicalTrials.gov

What this trial studies

This is an observational, multicenter project using MRI-derived radiological markers and multivariate machine-learning techniques to predict lack of symptomatic remission at three months in first-episode psychosis patients. Participants are antipsychotic-naive adults aged 18–35 diagnosed with schizophrenia-spectrum disorders and will undergo MRI and clinical follow-up. The study links changes in objective imaging markers with clinical measures over time to identify predictors of early non-response. Findings aim to refine early-care pathways by identifying patients who may need intensified or alternative interventions.

Who should consider this trial

Good fit: Ideal candidates are antipsychotic-naive adults aged 18–35 with a DSM-5 diagnosis of schizophrenia, schizoaffective, or schizophreniform disorder who can undergo MRI and provide informed consent.

Not a fit: Patients older than 35, those already treated with antipsychotics, pregnant or breastfeeding individuals, or those with MRI contraindications or major somatic/neurological disease are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, clinicians could identify likely non-responders early and tailor more intensive or alternative care plans sooner.

How similar studies have performed: Previous radiological studies and machine-learning work in neurology have shown promise for prediction, but applying MRI-based automatic learning specifically to predict three-month non-response in first-episode psychosis is relatively novel.

Eligibility criteria

Inclusion Criteria:

* men and women aged 18-35 years
* member or beneficiary of a social security scheme,
* for women, appropriate contraception will be mandatory, as well as a negative pregnancy test,
* patients with a diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder according to the DMS V
* having never received anti-psychotic treatment,
* followed in the hospital or outpatient,
* having given their written informed consent,
* that the physical examination revealed no significant clinical abnormalities

Exclusion Criteria:

* Female patients of childbearing period without effective contraception (oral, intramuscular hormonal, intrauterine device, or surgical);
* Patients pregnant or nursing;
* Presenting a serious somatic or neurological disease, especially Parkinson's disease, epilepsy, debilitating tardive dyskinesia, cardiovascular disease, severe liver or kidney;
* Featuring against-indication for an MRI; including: metallic foreign body eye or intracranial, pacemaker, heart valve, surgical clips, claustrophobia, large tattoo in the upper part of the body, not compatible with 3T MRI
* Having a history of alcohol or drug abuse in the past year;
* Participating in another clinical trial or being in an exclusion period of the previous protocol;
* Patients likely to exhibit aggressive behavior self according to the judgment of the investigators.

Where this trial is running

Bron and 4 other locations

• Chu Le Vinatier — Bron, France (Not_yet_recruiting)
• Chu Clermont-Ferrand — Clermont-Ferrand, France (Not_yet_recruiting)
• Chu Grenoble — Grenoble, France (Not_yet_recruiting)
• HÔPITAL Edouard Herriot — Lyon, France (Not_yet_recruiting)
• Chu Saint Etienne — Saint-Etienne, France (Recruiting)

Study contacts

• Principal investigator: Eric FAKRA, MD PhD — Centre Hospitalier Universitaire de Saint Etienne
• Study coordinator: Eric FAKRA, MD PhD

Conditions Schizophrenia