An observational study in Mood Disorders, sponsored by Assiut University. Not yet recruiting. Open to participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by Assiut University · Observational
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 90 is below the median of 150 across 950 observational studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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:
Major Medical or Neurological Diseases.
a. Inclusion criteria:
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
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
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
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
Time frame: 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
Time frame: baseline
No study locations are listed for this record.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Assiut University