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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chu Saint Etienne
  Saint-Etienne, France Recruiting
• 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

Study contacts

• Principal investigator: Eric FAKRA, MD PhD — Centre Hospitalier Universitaire de Saint Etienne
• Study coordinator: Eric FAKRA, MD PhD
• Email: eric.fakra@chu-st-etienne.fr
• Phone: (0)477127885

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.