Clinical trial NCT02670447: Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies
Official title: Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies: A Multicentric Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Schizophrenia
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2016-02-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering of schizophrenia will be included in this study. They do not have ever taken anti-psychotic treatment.

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.

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.

Primary outcomes:
measure: Score of the predictive value of the imagery markers.
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Chu Le Vinatier
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
city: Grenoble
country: France
facility: Chu Grenoble
city: Lyon
country: France
facility: HÔPITAL Edouard Herriot
city: Saint-Étienne
country: France
facility: Chu Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Eric FAKRA, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: