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NCT07173842

NeuroPsyBiT-BD Omics: Genomic & Epigenomic Biobank of Bipolar Disorder

Sponsor: Selçuk State Hospital

View on ClinicalTrials.gov

Summary

Brief Summary The goal of this observational study is to establish a comprehensive biobank and phenotypic data repository for patients diagnosed with bipolar disorder in Türkiye. The study will prospectively collect standardized clinical, demographic, lifestyle, and biological data to create a secure genomic and epigenomic research resource. The main questions it aims to answer are: Can large-scale, standardized phenotypic and biological data collection improve the understanding of bipolar disorder subtypes and disease course? Can integration of biobank samples with genomic and epigenomic analyses identify biomarkers that inform future diagnosis, prognosis, and treatment strategies? Participants will: Provide consent and demographic/clinical information using the NeuroPsyBiT Data Collector software. Contribute blood samples (e.g., EDTA tubes) for DNA extraction, genotyping, and future epigenomic studies. Allow secure storage of their data and biospecimens in the RTSGD biobank for use in ethically approved research projects. All data and samples will be collected and stored under strict ethical oversight and in compliance with national (KVKK) and international (GDPR) data protection regulations. Personally identifiable information will not be shared, and access to the biobank and dataset will only be granted after approval by institutional review boards and ethics committees. This registry will create the foundation for future genome-wide association studies (GWAS) and epigenome-wide association studies (EWAS), supporting the long-term goal of developing precision psychiatry tools for bipolar disorder.

Official title: Establishment of the NeuroPsyBiT-BD Omics Program: Development of a Turkish Bipolar Disorder Biobank Integrating Genomic and Epigenomic Profiling With Structured Clinical Phenotyping and Secure Data Infrastructure

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2025-10-01

Completion Date

2027-10-01

Last Updated

2025-09-15

Healthy Volunteers

Yes

Interventions

OTHER

Biobanking and Phenotypic Data Collection

This intervention involves the systematic collection of blood samples (EDTA tubes for DNA extraction) and detailed phenotypic/clinical data using the NeuroCybe Data Collector software. All biospecimens are processed and stored at the RTSGD-NeuroPsyBiT Biobank under ISO-compliant procedures. Data are entered into a secure on-premises server infrastructure (GDPR/KVKK compliant) for long-term use in genomic and epigenomic studies. No therapeutic intervention is applied; all activities are non-invasive and focused on sample and data acquisition.

Locations (1)

Selçuk University Faculty of Medicine, Department of Psychiatry / NeuroPsyBiT-RTSGD Consortium

Konya, Konya, Turkey (Türkiye)