Neuroinflammation Markers in Subjects With Psychotic Symptoms

NCT05815225 | Unknown

• 1 other identifier: NEUROINPS17
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Neuroinflammatory Response; Psychosis

Keywords

psychosis; cytokines; chemokines; endocannabinoid system

Outcome Measures

Primary Outcomes (4)

• Level of biomakers 1

  Levels of endocannabinoids and neuroinflammation mediators (cytokines and chemokines) in subjects with active psychotic symptoms

  Week 1

• Level of biomakers 2

  Levels of endocannabinoids and neuroinflammation mediators (cytokines and chemokines) in subjects with active psychotic symptoms

  Week 1-8

• Level of biomakers 3

  Levels of endocannabinoids and neuroinflammation mediators (cytokines and chemokines) in subjects with active psychotic symptoms

  Week 22-26

• Changes from Baseline level of biomarkers at 6 months

  Changes from Baseline level of biomarkers at 6 months

  Week 1 and Week 22-26

Secondary Outcomes (1)

• Rate of phenotype characteristics and clinical symptoms

  Week 22-26

Study Arms (3)

A: subjects from mental health unit

Subjects with active psychotic symptoms at the time of recruitment, attended at the Mental Health Clinical Management Unit of the Regional University Hospital of Malaga (Spain) and admitted to the Mental Health Hospitalization Unit. In turn, within this group, a cross-classification will be established according to the evolutionary staging of the disease, the concomitant presence of major affective symptoms and the consumption of substances in the weeks prior to admission.

B: subjects with induced psychoses

Subjects with psychotic symptoms, diagnosed with a substance-induced psychotic episode, already recruitedand previously characterized.

C: control group

Control group of volunteers extracted from the general population, without psychotic symptoms orsubstance use disorders.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A sample of subjects with psychotic symptoms (divided into several clinical subgroups) at different stages of their disease will be compared with another sample of patients with psychotic symptoms already recruited previously and a control group of people from the community without psychiatric pathology or substance use.

You may qualify if:

• Patients (men and women) with diagnostic criteria for psychotic episode, affective episode with psychotic symptoms, or substance-induced psychotic episode, according to DSM and ICD criteria.
• Age from 18 to 65 years.
• Informed consent.

You may not qualify if:

• Severe cognitive alterations that do not allow the application of diagnostic instruments.
• Infectious diseases \[Laboratory prophylaxis (HIV, Hepatitis B, C)\].
• Not speaking the Spanish language fluently.
• History of head trauma with loss of consciousness, stroke, or CNS disease.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Regional Universitario de Málaga

Málaga, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood collection at the 3 cut-off points. 18 mL of blood will be obtained in EDTA tubes (K2, K3). A tube will be used to obtain plasma, which will be frozen within an hour and a half after extraction. It is necessary to perform the centrifuge at 4º, obtaining as many aliquots of 500 microliters (at least 3) as possible. The remainder less than 500 ul will be stored in a single aliquot. The second tube will be used to obtain white blood cells according to the protocol established by the Biobank together with the research group. Cryopreservation will be done at -70ªC in the IBIMA Biobank.

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Fermín Mayoral-Cleríes, MD

  Hospital Regional de Malaga

  STUDY CHAIR

Central Study Contacts

Jesús Herrera-Imbroda, MD

CONTACT

+34 618 57 56 85; jesus.herrera.imbroda.sspa@juntadeandalucia.es

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: April 18, 2023
• Study Start: November 1, 2017
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: April 18, 2023

Record last verified: 2022-12

Locations

ES (1)