Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies

Официальное название

Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies: A Multicentric Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура MRI
  Magnetic Resonance Imagery will be performed on patients attempted by schizophrenia. The aim of this intervention is an early detection of the non-answering patients to the primary cares.

Первичные конечные точки

• Score of the predictive value of the imagery markers. [Срок оценки: Month 3]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Франция · 5 центров

• Chu Le Vinatier — Bron
• Chu Clermont-Ferrand — Clermont-Ferrand
• Chu Grenoble — Grenoble
• HÔPITAL Edouard Herriot — Lyon
• Chu Saint Etienne — Saint-Etienne

Идентификаторы

NCT: NCT02670447 · 1508174 · 2015-A01756-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗