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

NCT06877442 | Not Yet Recruiting

• 1 other identifier: NFL mood disorders
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

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

Conditions

Mood Disorders

Keywords

mood disorders; neurofilament light chain

Outcome Measures

Primary Outcomes (2)

• correlation of neurofilament light chain with severity of symptoms in mood disorders

  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

  correlation of serum level of neurofilament light chain and cognitive functions in mood disorders

  baseline

Study Arms (3)

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

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

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

Interventions

serum level of neurofilament light chain DIAGNOSTIC_TEST

labarotory investigation to evaluate serum level of neurofilament light chain

group A Patients with major depression; group B Bipolar Disorder; group C healthy control

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• age 15-50 years old
• both sexes will be included
• meet the Diagnostic And Statistical Manual Of Mental Disorders Fifth Edition (DSM-5) criteria for major depressive disorder or Bipolar disorder

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Bavato F, Barro C, Schnider LK, Simren J, Zetterberg H, Seifritz E, Quednow BB. Introducing neurofilament light chain measure in psychiatry: current evidence, opportunities, and pitfalls. Mol Psychiatry. 2024 Aug;29(8):2543-2559. doi: 10.1038/s41380-024-02524-6. Epub 2024 Mar 19.

  PMID: 38503931 BACKGROUND

• Jakobsson J, Bjerke M, Ekman CJ, Sellgren C, Johansson AG, Zetterberg H, Blennow K, Landen M. Elevated concentrations of neurofilament light chain in the cerebrospinal fluid of bipolar disorder patients. Neuropsychopharmacology. 2014 Sep;39(10):2349-56. doi: 10.1038/npp.2014.81. Epub 2014 Apr 3.

  PMID: 24694925 BACKGROUND

• Bavato F, Cathomas F, Klaus F, Gutter K, Barro C, Maceski A, Seifritz E, Kuhle J, Kaiser S, Quednow BB. Altered neuroaxonal integrity in schizophrenia and major depressive disorder assessed with neurofilament light chain in serum. J Psychiatr Res. 2021 Aug;140:141-148. doi: 10.1016/j.jpsychires.2021.05.072. Epub 2021 Jun 2.

  PMID: 34116440 BACKGROUND

• Aggio V, Fabbella L, Finardi A, Mazza EB, Colombo C, Falini A, Benedetti F, Furlan R. Neurofilaments light: Possible biomarker of brain modifications in bipolar disorder. J Affect Disord. 2022 Mar 1;300:243-248. doi: 10.1016/j.jad.2021.12.122. Epub 2021 Dec 31.

  PMID: 34979181 BACKGROUND

MeSH Terms

Conditions

Mood Disorders; Charcot-Marie-Tooth disease, Type 1F

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Wageeh A Hassan

  Assiut University

  STUDY CHAIR

• Hossam E Khalifa

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

waleed A Hamdy

CONTACT

01030968160; waleedashraf7@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03