NCT02670447 Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies
| NCT ID | NCT02670447 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Schizophrenia |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-12-11 |
| Primary Completion | 2030-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2025-12-11 with a primary completion date of 2030-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Eric FAKRA, MD PhD
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Saint Etienne
Frequently Asked Questions
Who can join the NCT02670447 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 35 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02670447 currently recruiting?
Yes, NCT02670447 is actively recruiting participants. Contact the research team at eric.fakra@chu-st-etienne.fr for enrollment information.
Where is the NCT02670447 trial being conducted?
This trial is being conducted at Bron, France, Clermont-Ferrand, France, Grenoble, France, Lyon, France and 1 additional location.
Who is sponsoring the NCT02670447 clinical trial?
NCT02670447 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The principal investigator is Eric FAKRA, MD PhD at Centre Hospitalier Universitaire de Saint Etienne. The trial plans to enroll 80 participants.
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