CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 178 enrolled
Drug / intervention
GFAP, S100Bother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05257720
NCT05257720N/ACompleted

Evaluation of the Role of Neurodegeneration in Treatment Resistant Schizophrenia With GFAP and S100B

Istanbul Saglik Bilimleri University·observational·Posted Feb 25, 2022·Updated Oct 28, 2022

In Brief

An observational study evaluating GFAP, S100B for Schizophrenia. Completed, enrolled 178 participants across 1 site.

Detailed Summary

Schizophrenia is a progressive psychiatric disorder with a lifetime prevalence of 1%, its etiology is not fully understood, and it progresses with relapses. There are significant differences between patients in the age of onset, frequency of attacks, response to treatment, and clinical course of the disease. Failure to respond adequately to treatment is defined as resistance to treatment and poses a great challenge in the clinical management of the disease, but the exact cause of treatment resistance has not been clarified yet. Neurodevelopmental hypothesis, neurodegenerative hypothesis, stress-diathesis hypothesis are some of them. In the neurodegenerative hypothesis, it is thought that biochemical changes cause chronic and progressive disorders of the nervous system, and schizophrenia is considered as one of these disorders. S100B, one of the biomarkers released from the central nervous system, is a glycoprotein synthesized by astrocytes; At low concentration, it ensures neuron survival, while at high concentration it causes neuronal cell apoptosis and is associated with neurodegeneration. GFAP on the other hand, can be measured in serum in proportion to the degree of damage by passing into the bloodstream as a result of astrocyte damage. It has been shown that these markers are associated with neurodegenerative diseases, autoimmune diseases and cerebrovascular pathologies and can be measured at a significant level in the blood. As far as is known, neurodegeneration has been found in patients with schizophrenia; however, there are not enough studies in the literature regarding the relationship of this neurodegeneration with treatment response and resistance. In recent years, many biomarker studies related to schizophrenia have been conducted. These studies continue in many different areas such as the early diagnosis of schizophrenia, the treatments to be applied after diagnosis, the response to the treatment given, and the clinical course of the disease, but no biomarker indicating the desired results has yet been found. In this study, measurement of s100B and GFAP serum levels in patients with treatment-resistant schizophrenia, remission schizophrenia and healthy controls, and evaluation of their relationship with response to treatment; Thus, it is aimed to investigate these points that have not been fully elucidated in the pathogenesis of schizophrenia and their use as biomarkers in predicting the response to treatment.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedFeb 25, 2022
Enrollment StartMar 28, 2022
Primary CompletionAug 1, 2022
Study CompletionOct 1, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.4 years ago

Interventions

GFAP, S100Bother

It is planned to measure serum GFAP and S100 B protein levels by ELISA method.