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

NCT07173842 | Not Yet Recruiting DMC

• 4 other identifiers: NEUROPSYBIT-BD-001TÜBİTAK 1505RTSGD-BD-BIOBANK-2025to be updated after approval
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Mood Disorders; Psychiatric Genetics; Epigenomics; GWAS; EWAS; Biobank; Phenotyping

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Successfully Collected and Biobanked DNA Samples

  Count of bipolar disorder participants whose blood samples (EDTA tubes) are successfully collected, processed, quality-checked (DNA yield/purity), and stored in the RTSGD-NeuroPsyBiT Biobank under ISO standards

  From enrollment to 24 months

Secondary Outcomes (3)

• Completeness of Phenotypic Dataset per Participant

  24 months

• Proportion of Biobanked Samples Ready for Genomic/Epigenomic Analysis

  24 months

• Rate of Successful Data-Sample Linkage

  24 months

Study Arms (2)

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.

Other: Biobanking and Phenotypic Data Collection

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.

Other: Biobanking and Phenotypic Data Collection

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.

Bipolar Disorder Patients; Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited through the Department of Psychiatry at Selçuk University Medical Faculty in Konya, Türkiye, in collaboration with the Research and Treatment Society of Genetic Disorders (RTSGD) and the NeuroPsyBiT Consortium. The population includes adults aged 18-65 diagnosed with bipolar disorder who receive outpatient or inpatient psychiatric care at Selçuk University clinical facilities, as well as healthy control volunteers recruited from the local community and hospital staff. Both patient and control groups will contribute to the establishment of a national biobank and phenotypic data registry designed to support future genomic and epigenomic studies

You may qualify if:

• Age 18-65 years.
• DSM-5 diagnosis of Bipolar I, II and NOS confirmed by SCID-5.
• Able to provide written informed consent.
• Willing to complete standardized phenotyping (e.g., YMRS, HDRS-17, FAST/WHODAS) and to provide biospecimens (minimum: whole blood in EDTA; optional: serum, plasma, PAXgene-RNA, cfDNA tubes).
• Stable psychotropic regimen for ≥14 days prior to sampling or drug-free for ≥14 days.
• Age 18-65 years.
• No lifetime DSM-5 psychiatric disorder (including bipolar and schizophrenia spectrum and others) by SCID-5.
• No first-degree family history of major psychiatric disorder (including bipolar and schizophrenia spectrum).
• Able to provide informed consent and blood samples for biobanking.
• No current psychotropic medication.

You may not qualify if:

• Presence of neurological disorders (e.g., epilepsy, multiple sclerosis, Parkinson's disease).
• Severe, uncontrolled medical illness that could affect participation or biological measures (e.g., decompensated cardiac, renal, hepatic, or endocrine disease).
• Active infection or fever within 14 days; systemic corticosteroids or immunomodulators within 30 days; vaccination within 14 days.
• Blood transfusion within 3 months or blood donation within 2 weeks prior to sampling.
• Current substance use disorder.
• Pregnancy or breastfeeding at enrollment.
• Inability to comply with procedures or lack of capacity to consent (e.g., significant cognitive impairment, severe language barrier), or acute mania/psychosis requiring immediate hospitalization.

Sponsors & Collaborators

• Selçuk State Hospital: lead
• Research and Treatment Society of Genetic Disorders: collaborator

Study Sites (1)

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

Konya, Konya, 42130, Turkey (Türkiye)

Location

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Related Links

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Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples will be collected in EDTA tubes from individuals diagnosed with bipolar disorder. DNA will be extracted from these samples for use in genomic and epigenomic analyses, including genome-wide association studies (GWAS) and epigenome-wide association studies (EWAS). Plasma and buffy coat fractions may also be stored for future biomarker studies. All biospecimens will be processed and stored under ISO-compliant biobanking standards with barcode tracking to ensure quality, traceability, and secure long-term retention.

MeSH Terms

Conditions

Bipolar Disorder; Mood Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mental Disorders

Central Study Contacts

Ali Torabi, MD., Phd.

CONTACT

+90 552 304 2215; ali.torabi@rtsgd.org.tr

Mehmed Ediz Çelik, MD.

CONTACT

+90 506 673 83 74; m.ediz.Celik@rtsgd.org.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Individual Participant Data (IPD) and supporting documentation (Study Protocol, SAP, ICF, Analytic Code) will become available 12 months after study completion and will remain accessible for 5 years under controlled access agreements. After this period, renewal of access may be possible upon approval by the sponsor and the Turkish Health Ministry.
• Access Criteria: Only qualified researchers affiliated with recognized academic or clinical institutions may apply. Requests must be accompanied by a formal research proposal, including clear objectives, methodology, and justification for data use. All requests require Ethics Committee approval and explicit authorization from the Turkish Ministry of Health. Data will be shared only in a de-identified, encrypted format via a secure on-premises or ministry-approved platform. No direct downloads or cloud transfer will be allowed. Applicants must sign a Data Use Agreement (DUA), prohibiting re-identification attempts, redistribution, or secondary use beyond the approved proposal. Publication of analyses derived from the IPD will require pre-review by the sponsor consortium (RTSGD/NeuroPsyBiT) to ensure compliance with ethical, legal, and scientific standards. Violations of these criteria will result in immediate termination of access and legal consequences under Turkish data protection laws (KVKK) an

Locations

TU (1)