Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies: A Multicentric Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Enrollment
- 80
- Locations
- 5
- Primary Endpoint
- Score of the predictive value of the imagery markers.
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Detailed Description
Recently, radiological markers demonstrated a good capacity to discriminate first episode of psychosis patients, that will show a bad response to treatment. Furthermore, automatic learning methods were recently successfully applied to neurological data, but never for the first episode psychosis patients. These powerful methods are based on multivariate analyses allowing the prediction at an individual stage. The possibility to identify more precisely the population of non-answering patients would allow the adaptation of the support in first attention for these patients, and consequently to perform appropriate cares. 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.
Investigators
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.
Outcomes
Primary Outcomes
Score of the predictive value of the imagery markers.
Time Frame: Month 3
Evaluate the predictive value for the imagery markers on the therapeutic non-answer at month 3 for patients presenting a first psychotic episode.