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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-12-30

Brief Summary

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* 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

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Detailed Description

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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.

Conditions

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Mood Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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group A Patients with major depression

meet the Diagnostic And Statistical Manual Of Mental Disorders Fifth Edition (DSM-5) criteria for major depressive disorder they will undergo the following

1. Hamilton depression rating scale
2. montreal cognitive assessment c, serum level of neurofilament light chain

serum level of neurofilament light chain

Intervention Type DIAGNOSTIC_TEST

labarotory investigation to evaluate serum level of neurofilament light chain

group B Bipolar Disorder

meet the Diagnostic And Statistical Manual Of Mental Disorders Fifth Edition (DSM-5) criteria for Bipolar Disorder they will undergo the following

1. young mania rating scale
2. montreal cognitive assessment
3. serum level of neurofilament light chain

serum level of neurofilament light chain

Intervention Type DIAGNOSTIC_TEST

labarotory investigation to evaluate serum level of neurofilament light chain

group C healthy control

not known to have any medical or mental illness they will undergo the following

1. montreal cognitive assessment
2. serum level of neurofilament light chain

serum level of neurofilament light chain

Intervention Type DIAGNOSTIC_TEST

labarotory investigation to evaluate serum level of neurofilament light chain

Interventions

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serum level of neurofilament light chain

labarotory investigation to evaluate serum level of neurofilament light chain

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

1. age- and sex-matching with group A, B
2. Healthy Control without any of major physical conditions or psychiatric disorder

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

Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No