NCT05257720

Evaluation of the Role of Neurodegeneration in Schizophrenia

Completed Last updated 28 October 2022

What this trial tests

trial testing GFAP, S100B in Schizophrenia in 178 participants. Completed in 1 October 2022.

Timeline

28 March 2022

Primary endpoint
1 August 2022

1 October 2022

Quick facts

Lead sponsor	Istanbul Saglik Bilimleri University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	178
Start date	28 March 2022
Primary completion	1 August 2022
Estimated completion	1 October 2022
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• GFAP, S100B

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →

Sponsor

Istanbul Saglik Bilimleri University

Who can join

Adults 18 to 65, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Immune System Alterations in Treatment-Resistant Schizophrenia: A Systematic Review of the Current Evidence and Future Directions.
   Krzystanek M, Bieś R, Bąk-Sosnowska M. · · 2026 · PMID 42123331 · DOI 10.3390/ijms27093745