Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies
Recruiting · NCT02670447 · Observational (researchers observe without assigning treatment) · Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
View the official record on ClinicalTrials.gov →Interventions studied
MRI
What this trial is about
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.
Who can take part
Age range
18 Years to 35 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
5 locations listed.
- Chu Le Vinatier - Bron, France
- Chu Clermont-Ferrand - Clermont-Ferrand, France
- Chu Grenoble - Grenoble, France
- HÔPITAL Edouard Herriot - Lyon, France
- Chu Saint Etienne - Saint-Etienne, France