Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05815225
Status:
RECRUITING
Last Update Posted:
2023-04-18
First Post:
2023-02-01
Brief Title:
Neuroinflammation Markers in Subjects With Psychotic Symptoms
Sponsor:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Organization:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study Overview
Official Title:
Neuroinflammation Markers in Subjects With Psychotic Symptoms
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEUROINPS17
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
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
Detailed 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 500000 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 Fishers exact formula in the case of qualitative variables and by Students 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 p005 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 Fishers exact test or chi-square test and Students 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 Pearsons 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
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 500000 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 Fishers exact formula in the case of qualitative variables and by Students 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 p005 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 Fishers exact test or chi-square test and Students 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 Pearsons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None