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

ConditionSchizophrenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-35
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients suffering of schizophrenia will be included in this study. They do not have ever taken anti-psychotic treatment.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • MRI

    Procedure/Surgery

    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.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: First episode of psychosis patients1 intervention

Trial outcomes

Primary outcomes

1

Score of the predictive value of the imagery markers.

To evaluate the predictive value of imaging markers (morphological and structural connectivity imaging) for the absence of remission at 3 months in patients with PEP.

Time frame
Month 3

Secondary outcomes

Other outcomes

Sponsors and contacts

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