Actively Recruiting
Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2025-12-19
80
Participants Needed
5
Research Sites
276 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Saint Etienne
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers propose in this project to evaluate predictive factors of non response. It is defined by the lack of symptomatic remission at month 3, for patients presenting a first episode of psychosis. It will be performed on objective markers taken from imagery techniques. The link between evolution of these markers and clinical measures will be studied.
CONDITIONS
Official Title
Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Chu Le Vinatier
Bron, France, 69500
Not Yet Recruiting
2
Chu Clermont-Ferrand
Clermont-Ferrand, France, 63003
Not Yet Recruiting
3
Chu Grenoble
Grenoble, France, 38000
Not Yet Recruiting
4
HÔPITAL Edouard Herriot
Lyon, France, 69003
Not Yet Recruiting
5
Chu Saint Etienne
Saint-Etienne, France, 42100
Actively Recruiting
Research Team
E
Eric FAKRA, MD PhD
CONTACT
M
Marlène BONNEFOI, Project manager
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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