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

Sponsor
Selçuk State Hospital
Study ID
NCT07173842
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Biobanking and Phenotypic Data Collection — OTHER
    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.

Study Details

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.

Key Dates

First listed
Sep 15, 2025
Start date
Oct 1, 2025
Status verified
Sep 2025
Primary completion
Oct 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Bipolar Disorder Patients
    Participants clinically diagnosed with bipolar disorder, recruited under ethics committee-approved protocols. Detailed phenotypic, clinical, and psychosocial parameters will be collected using the NeuroCybe Data Collector system. Biospecimens (e.g., EDTA blood samples) will be stored in the RTSGD-NeuroPsyBiT Biobank under ISO-compliant standards.
  • Arm: Control Group
    Healthy volunteers without a history of psychiatric disorders, matched for key demographic variables (age, sex). Biospecimens and phenotypic data will be collected following the same standardized procedures as the patient cohort. Controls provide baseline references for genomic, epigenomic, and phenotypic comparisons.

Primary Outcome Measure

Number of Participants with Successfully Collected and Biobanked DNA Samples [ Time Frame: From enrollment to 24 months ]

Central Contacts

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