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

March 10, 2025 updated by: waleed ashraf hamdy ahmed, Assiut University

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

  • 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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Participants will be divided into three groups (A) Patients with Major depressive episode (B) Patients with Bipolar Disorder Manic Episode (C) Healthy control thirty participants in each group from 15-50 years old amtching in age and sex with each group

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: serum level of neurofilament light chain
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
Diagnostic test: serum level of neurofilament light chain
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
Diagnostic test: serum level of neurofilament light chain
labarotory investigation to evaluate serum level of neurofilament light chain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation of neurofilament light chain with severity of symptoms in mood disorders
Time Frame: baseline
correlation of serum level of neurofilament light chain and severity of symptoms in mood disorders
baseline
correlation of neurofilament light chain with cognitive function in mood disorders
Time Frame: baseline
correlation of serum level of neurofilament light chain and cognitive functions in mood disorders
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Hossam E Khalifa, Assiut University
  • Study Chair: Wageeh A Hassan, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFL mood disorders

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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