Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05815225 |
| Other study ID # |
NEUROINPS17 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2017 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
December 2022 |
| Source |
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud |
| Contact |
Jesús Herrera-Imbroda, MD |
| Phone |
+34 618 57 56 85 |
| Email |
jesus.herrera.imbroda.sspa[@]juntadeandalucia.es |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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 clinical and evolutive 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 induced 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 study has two parts. The first one is an observational, longitudinal and prospective
study. 3 blood draws will be performed from the subjects included in the study (group A of
participants, see below): 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 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). Figure 1 represents this study.
The second one is a cross-sectional study in which we will compare measurements made in group
A participants with a previously recruited sample of patients with substance-induced
psychosis (group B, see below) and a sample of healthy, non-psychotic controls (group C, see
below).
The rater team will be composed of senior psychiatrists and training psychiatrists. 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 analyzed using statistical programs.
This study will be carried out in a brief psychiatric hospitalization unit located in the
city of Malaga (Andalusia, Spain) and has 42 beds for a catchment area of approximately
500.000 inhabitants. This unit is part of the Mental Health care system within the Andalusian
Health Service, which provides universal health coverage to all people living in the
autonomous community. The mental health department of the hospital also comprises other units
such as two community mental health centers, one day center, one medium- and long-stay ward
(30 beds), one child and adolescent mental health unit, an intensive community treatment
team, a care team for first episodes of psychosis, and an eating disorders unit.
The process of collecting clinical data and extracting peripheral blood will be carried out
as follows:
1. Signature of the informed consent and appointment for evaluation process.
2. Venous blood collection at the 3 cut-off points listed above. 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.
3. Apply clinical evaluation instruments (see section assessment instruments).
4. The plasma evaluation of the concentrations of the molecular species differences:
N-acylethanolamines, 2-acylglycerols and cytokines (including chemokines) will be
carried out in the laboratory of the Civil Hospital of Málaga.
5. The samples will be processed and stored in the Biobank of the Civil Hospital of Málaga.
Both qualitative and quantitative descriptive statistics will be used to characterize the
sample that has participated in the study as demographic and diagnostic information.
Demographics. Comparisons between groups or hypothesis testing will be made by the Chi Square
test (χ2) or Fisher's exact formula in the case of qualitative variables and by Student's T
statistic or analysis of variance (ANOVA) in the case of quantitative variables. Non
parametric test (Mann-Whitney test and Kruskal-Wallis) will be used if the distributions not
follow normality. For all hypothesis testing a probability p<0.05 will be considered
significant.
Clinical and biochemical data. The results will be expressed with the number of subjects and
respective percentage, as well as by means of the means and standard deviations (SD).
Statistical significations will be determined by Fisher's exact test or chi-square test and
Student's t-test (Welch correction with unequal variances). For comparison, between the one-
and two-way groups, analyses of variance followed by the post hoc test of multiple
comparisons (Bonferroni test) will be used. Correlation analyses will be performed through
Pearson's coefficient. In addition, the receiver operating characteristics (ROC) will be
analyzed taking into account the area under the curve (AUC) and these will be used to
generate regression models which in turn will create predictors.
