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Neurofilament Light Chain Correlation With Severity of Symptoms and Cognitive Decline in Mood Disorders

Correlation of Neuronal Cytoskeletal Integrity With Severity of Symptoms and Cognitive Decline In Mood Disorders

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06877442
Enrollment
90
Registered
2025-03-14
Start date
2025-05-01
Completion date
2026-12-30
Last updated
2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mood Disorders

Keywords

mood disorders, neurofilament light chain

Brief summary

* Explore correlation of neurofilament light chain serum level and severity of symptoms and cognitive impairment in mood disorders * Explore How novel brain markers as neurofilament light chain can be useful in detection and prognosis of mood disorders

Detailed description

Cytoskeletal integrity, represented by neurofilament light chain (NfL), has emerged as a critical biomarker for neuroaxonal injury, with growing evidence linking it to mood disorders such as major depressive disorder (MDD) and bipolar disorder (BD). Neurofilaments are structural proteins essential for maintaining neuronal stability, and NfL, the smallest subunit, is released into extracellular fluids like cerebrospinal fluid (CSF) and blood following neuronal damage. Recent advancements in immunoassay technologies have enabled the reliable quantification of NfL in peripheral blood, providing a minimally invasive method to assess brain pathology (1). Mood disorders are characterized by structural brain alterations, including reduced white matter integrity and gray matter volume loss, suggesting underlying neuroaxonal damage. Elevated blood NfL levels have been reported in patients with Major Depressive Disorder and Bipolar Disorder , with increases ranging from 1.2 to 2.5-fold compared to healthy controls, indicating a potential link between cytoskeletal disruption and mood disorder pathology (1,2). In MDD, higher NfL levels have been associated with cognitive dysfunction and white matter abnormalities, highlighting the role of cytoskeletal integrity in disease severity (3). Similarly, in Bipolar Disorder, elevated NfL levels have been linked to cognitive deficits and structural brain changes, particularly during acute episodes, further supporting the involvement of neuroaxonal injury in mood disorder progression (2,4). However, the interpretation of NfL levels in mood disorders is complicated by factors such as age, body mass index (BMI), and cardiovascular risk factors, which influence NfL variability (1). Despite these challenges, NfL holds promise as a biomarker for assessing cytoskeletal integrity and monitoring disease progression in mood disorders, offering new insights into their neurobiological underpinnings. Further research is needed to elucidate the mechanisms driving NfL release and its clinical utility in psychiatric practice.

Interventions

DIAGNOSTIC_TESTserum level of neurofilament light chain

labarotory investigation to evaluate serum level of neurofilament light chain

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
15 Years to 50 Years

Inclusion criteria

Participants will be divided into three groups (A) Patients with Major depressive episode (B) Patients with Bipolar Disorder Manic Episode 1. Inclusion criteria: 1. age 15-50 years old 2. both sexes will be included 3. meet the Diagnostic And Statistical Manual Of Mental Disorders Fifth Edition (DSM-5) criteria for major depressive disorder or Bipolar disorder 2.

Exclusion criteria

1. Major Medical or Neurological Diseases. 2. History of Traumatic Brain Injury, Major Fracture. 3. Alcohol or Substance Use Disorder. (C) Healthy control a. Inclusion criteria: 1. age- and sex-matching with group A, B 2. Healthy Control without any of major physical conditions or psychiatric disorder

Design outcomes

Primary

MeasureTime frameDescription
correlation of neurofilament light chain with severity of symptoms in mood disordersbaselinecorrelation of serum level of neurofilament light chain and severity of symptoms in mood disorders
correlation of neurofilament light chain with cognitive function in mood disordersbaselinecorrelation of serum level of neurofilament light chain and cognitive functions in mood disorders

Contacts

Primary Contactwaleed A Hamdy
waleedashraf7@yahoo.com01030968160

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026