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Neuroinflammation Markers in Subjects With Psychotic Symptoms

NCT05815225 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2023-04-18

No results posted yet for this study

Summary

The main objective of the study is to measure the plasma and intracellular levels of several neuroinflammation markers (including cytokines and chemokines) and the endocannabinoid system in subjects presenting psychotic symptoms, initially recruited in a Mental Health Hospitalization Unit, and in different stages of their disease.

To this end, we will evaluate and clinically characterize a cohort of patients who present active psychotic symptoms at the time of recruitment, and comparing it with a control group with similar sociodemographic characteristics. We will also compare our sample with a smaller sample previously recruited from patients with substance use and psychotic symptoms. Within our cohort of patients with psychotic symptomatology we will distinguish in turn affective psychoses from non-affective psychoses, on the one hand; and induced and non-induced psychosis by drug consumption, on the other. We will also classify patients based on whether they are experiencing the first episode of their illness or a relapse.

This is an observational, longitudinal and prospective study. 3 blood draws will be performed from the subjects included in the study: the first, in the first 48 hours of hospital admission; the second, in the 48 hours prior to discharge; and the third, 6 months after discharge. The rater team will be composed of senior psychiatrists and training psychiatrists. The sample will be composed of subjects with psychotic symptoms who come from the Mental Health Clinical Management Unit of the Regional University Hospital of Malaga. Each patient enrolled in this study will undergo a clinical evaluation (psychiatric diagnostic interview and psychometric scales). From the plasma and white blood cells of the blood sample, the biochemical levels of the inflammatory mediators will be determined. Demographic, clinical, and biochemical data will be assessed and analysed using statistical programmes.

Conditions

Sponsors & Collaborators

  • Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

    lead OTHER

Principal Investigators

  • Fermín Mayoral-Cleríes, MD · Hospital Regional de Malaga

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05815225 on ClinicalTrials.gov