Epigenetic and Neurochemical Correlates of Bipolar Disorder

NCT06829316 | Not Yet Recruiting

• 1 other identifier: Biomarkers in BD
• Study Type: observational
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim of Study:

• To assess DNA methylation of the IL1-B gene in individuals with BD compared to healthy controls.
• To evaluate the expression of 5-hydroxytryptamine (serotonin) receptors in BD and shed more light into its role into the pathophysioogy of BD.
• To measure differences of glutamic acid levels between study groups.
• To investigate correlations between these biomarkers among study groups, and their alignment with clinical presentations.

Conditions

Bipolar Disorder (BD)

Outcome Measures

Primary Outcomes (1)

• Biomarker levels measurement

  Measurement and comparison of levels of DNA methylation of IL-1B gene, Serotonin receptor expression, and glutamic acid levels between study groups. Identifying correlations and possible ties to pathophysiology of BD.

  Within 6 months of sample collection

Study Arms (3)

Group I - Patients

Patients diagnosed with BD Diagnosis of BD will be established based on the diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

Group II

Unaffected first-degree relatives of patients with BD in group II

Group III - Controls

Age and sex matched healthy individuals without a direct family history of BD as controls

Eligibility Criteria

• Age: 18 Months - 45 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

A comprehensive medical history and physical examination will be conducted for all participants. Diagnosis of BD will be established based on the diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

You may qualify if:

• \- Adults aged 18-45 with diagnosis of BD type I.
• Informed consent.

You may not qualify if:

• \- Patients who have a concurrent severe illness or inflammatory disorders will be excluded. (e.g., other CNS disorders, autoimmune diseases, cancers... etc.)
• Current substance abuse.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• Mahmood T, Silverstone T. Serotonin and bipolar disorder. J Affect Disord. 2001 Sep;66(1):1-11. doi: 10.1016/s0165-0327(00)00226-3.

  PMID: 11532527 BACKGROUND

• Grezenko H, Ekhator C, Nwabugwu NU, Ganga H, Affaf M, Abdelaziz AM, Rehman A, Shehryar A, Abbasi FA, Bellegarde SB, Khaliq AS. Epigenetics in Neurological and Psychiatric Disorders: A Comprehensive Review of Current Understanding and Future Perspectives. Cureus. 2023 Aug 23;15(8):e43960. doi: 10.7759/cureus.43960. eCollection 2023 Aug.

  PMID: 37622055 BACKGROUND

• Cherlyn SY, Woon PS, Liu JJ, Ong WY, Tsai GC, Sim K. Genetic association studies of glutamate, GABA and related genes in schizophrenia and bipolar disorder: a decade of advance. Neurosci Biobehav Rev. 2010 May;34(6):958-77. doi: 10.1016/j.neubiorev.2010.01.002. Epub 2010 Jan 7.

  PMID: 20060416 BACKGROUND

• Kapczinski F, Dias VV, Kauer-Sant'Anna M, Brietzke E, Vazquez GH, Vieta E, Berk M. The potential use of biomarkers as an adjunctive tool for staging bipolar disorder. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Nov 13;33(8):1366-71. doi: 10.1016/j.pnpbp.2009.07.027. Epub 2009 Aug 8.

  PMID: 19666076 BACKGROUND

• Fortinguerra S, Sorrenti V, Giusti P, Zusso M, Buriani A. Pharmacogenomic Characterization in Bipolar Spectrum Disorders. Pharmaceutics. 2019 Dec 21;12(1):13. doi: 10.3390/pharmaceutics12010013.

  PMID: 31877761 BACKGROUND

• Machado-Vieira R, Courtes AC, Zarate CA Jr, Henter ID, Manji HK. Non-canonical pathways in the pathophysiology and therapeutics of bipolar disorder. Front Neurosci. 2023 Aug 1;17:1228455. doi: 10.3389/fnins.2023.1228455. eCollection 2023.

  PMID: 37592949 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

A 10 mL sample of venous blood will be collected from the antecubital vein under aseptic conditions and divided into two tubes. The first tube, containing anticoagulant (EDTA), will be centrifuged at 5000 rpm for 10 minutes. The separated plasma will then be stored at -20°C until biomarker analysis. The second tube will be stored as whole blood for subsequent DNA and RNA extraction. IL1B will be measured by DNA methylation of its gene using a DNA methylation kit (PCR). Serotonin receptors will be measured by their gene expression (PCR). Glutamic acid levels will be measured by ELISA.

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Central Study Contacts

Sarah S Mostafa, MBBS

CONTACT

+201097944528; sarahmostafa98@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: March 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 30, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-02