Schizophrenia Clinical Trial
— PEPsyOfficial title:
Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies: A Multicentric Study
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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | August 2030 |
Est. primary completion date | August 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Chu Le Vinatier | Bron | |
France | Chu Clermont-Ferrand | Clermont-Ferrand | |
France | Chu Grenoble | Grenoble | |
France | HÔPITAL Edouard Herriot | Lyon | |
France | Chu Saint Etienne | Saint-Étienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne | Ministry of Health, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score of the predictive value of the imagery markers. | Evaluate the predictive value for the imagery markers on the therapeutic non-answer at month 3 for patients presenting a first psychotic episode. | Month 3 |
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