Mood DisordersNCT06877442
Neurofilament Light Chain Correlation With Severity of Symptoms and Cognitive Decline in Mood Disorders
An observational study of Mood Disorders, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Mood Disorders
- What is being tested?
- serum level of neurofilament light chain
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- Child, Adult
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
Participants will be divided into three groups (A) Patients with Major depressive episode (B) Patients with Bipolar Disorder Manic Episode
- Inclusion criteria:
- 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
- Exclusion criteria:
- Major Medical or Neurological Diseases.
- History of Traumatic Brain Injury, Major Fracture.
- Alcohol or Substance Use Disorder. (C) Healthy control
- Inclusion criteria:
- age- and sex-matching with group A, B
- Healthy Control without any of major physical conditions or psychiatric disorder
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Conditions
- Mood Disorders
- Being tested
- serum level of neurofilament light chain
- Keywords
- mood disorders, neurofilament light chain
- Medical subject headings
- Mood Disorders, Charcot-Marie-Tooth disease, Type 1F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum level of neurofilament light chainDiagnostic test
labarotory investigation to evaluate serum level of neurofilament light chain
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: serum level of neurofilament light chain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, waleed ashraf hamdy ahmed, Assiut University
- Investigators
- Wageeh A Hassan, Study chair, Assiut UniversityHossam E Khalifa, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877442
- Sponsor's protocol ID
- NFL mood disorders
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38503931Jakobsson 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.
PubMed 24694925Bavato 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.
PubMed 34116440Aggio 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.
PubMed 34979181
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Neuronal Cytoskeletal Integrity With Severity of Symptoms and Cognitive Decline In Mood Disorders
- ClinicalTrials.gov ID
- NCT06877442
- Acronym / sponsor ID
- NFL mood disorders
- Conditions
- Mood Disorders
- Keywords
- mood disorders, neurofilament light chain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A Patients with major depression | – | Diagnostic Test: serum level of neurofilament light chainmeet 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 |
| group B Bipolar Disorder | – | Diagnostic Test: serum level of neurofilament light chainmeet 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 |
| group C healthy control | – | Diagnostic Test: serum level of neurofilament light chainnot known to have any medical or mental illness they will undergo the following 1. montreal cognitive assessment 2. serum level of neurofilament light chain |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Age groups
- Child, Adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum level of neurofilament light chainlabarotory investigation to evaluate serum level of neurofilament light chain | Diagnostic test | group A Patients with major depression, group B Bipolar Disorder, group C healthy control |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Background: PubMed 38503931Bavato 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.
- Background: PubMed 24694925Jakobsson 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.
- Background: PubMed 34116440Bavato 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.
- Background: PubMed 34979181Aggio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wageeh A Hassan study chair
Assiut University
Hossam E Khalifa study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Mood Disorders, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact waleed A Hamdy (01030968160, waleedashraf7@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation of neurofilament light chain with severity of symptoms in mood disorders (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06877442, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.