NCT02670447

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
60mo left

Started Dec 2025

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Dec 2025Apr 2031

First Submitted

Initial submission to the registry

January 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
9.9 years until next milestone

Study Start

First participant enrolled

December 11, 2025

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2031

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

4.3 years

First QC Date

January 28, 2016

Last Update Submit

December 12, 2025

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

First episode of psychosis patients

Patients with schizophrenia will be studied in this clinical trial, and that have never received anti-psychotic treatment. They will perform an MRI.

Procedure: MRI

Interventions

MRIPROCEDURE

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.

Also known as: Magnetic Resonance Imagery
First episode of psychosis patients

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • Patients likely to exhibit aggressive behavior self according to the judgment of the investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Chu Le Vinatier

Bron, 69500, France

NOT YET RECRUITING

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

NOT YET RECRUITING

Chu Grenoble

Grenoble, 38000, France

NOT YET RECRUITING

HÔPITAL Edouard Herriot

Lyon, 69003, France

NOT YET RECRUITING

Chu Saint Etienne

Saint-Etienne, 42100, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be taken for every patient to make toxicological tests.

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Eric FAKRA, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric FAKRA, MD PhD

CONTACT

(0)477127885eric.fakra@chu-st-etienne.fr

Marlène BONNEFOI, Project manager

CONTACT

(0)477120826marlene.bonnefoi@chu-st-etienne.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 1, 2016

Study Start

December 11, 2025

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2031

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)