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

September 8, 2025 updated by: Rukiye Tekdemir, Selçuk State Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This project, NeuroPsyBiT-BD-001: Genomic & Epigenomic Biobank of Bipolar Disorder, is an observational patient registry designed to establish a large-scale biobank and standardized phenotypic data platform for individuals with bipolar disorder in Türkiye.

Objectives and Rationale:

Bipolar disorder (BD) is a chronic and heterogeneous psychiatric condition with high morbidity, relapse rates, and unmet clinical needs. Genetic and epigenetic factors are believed to play a central role in its pathogenesis, yet reliable biomarkers remain scarce. By combining deeply phenotyped clinical data with biological samples, this registry seeks to create a robust foundation for genome-wide association studies (GWAS) and epigenome-wide association studies (EWAS). This approach will enable future biomarker discovery, stratification of subtypes, and exploration of treatment response predictors.

Study Design:

Population: Patients diagnosed with bipolar disorder according to DSM-5 criteria will be recruited through the NeuroPsyBiT consortium, a partnership between the Research and Treatment Society of Genetic Disorders (RTSGD) and the Department of Psychiatry at Selçuk University Medical Faculty.

Sample Size: The initial target is 500 patients in the first phase, with an expansion goal of ≥1,000 patients within one year.

Data Collection: Phenotypic and clinical data (>250 variables) will be systematically recorded using the NeuroCybe Data Collector, a proprietary software platform developed for standardized psychiatric data capture. Domains include demographics, medical/psychiatric history, clinical course, comorbidities, lifestyle/exposome, treatments, and psychometric assessments.

Biospecimen Collection: Blood samples (EDTA tubes) will be collected for DNA extraction, genotyping, and future methylation profiling. Samples will be processed and stored under ISO-compliant biobanking standards, ensuring traceability and long-term integrity.

Infrastructure and Data Security:

Biobank Management: RTSGD laboratories will serve as the central biobank facility, operating under internationally recognized quality standards for sample processing and storage.

Data Governance: All phenotypic and genotypic data will be securely stored on RTSGD on-premise servers with no cloud storage permitted.

Ethics & Privacy: Data handling will strictly comply with national (KVKK) and international (GDPR) regulations. Personally identifiable information will be de-identified. Data access will only be granted following approval by both institutional ethics committees and the Turkish Ministry of Health.

Future Access: De-identified datasets and biospecimens will be made available for national and international collaboration upon direct application to the consortium, subject to ethical approvals.

Scientific Impact:

This registry represents the first large-scale, ISO-standardized biobank for bipolar disorder in Türkiye. By unifying deep phenotyping with genomic and epigenomic resources, it will:

Enable high-resolution GWAS and EWAS in BD.

Provide a resource for cross-cohort meta-analysis and replication studies.

Facilitate translational research toward precision psychiatry approaches (diagnostic tools, risk stratification, and individualized treatment).

Create a sustainable national and international platform for collaboration in psychiatric genetics and epigenetics.

Long-term Vision:

The NeuroPsyBiT-BD registry is designed as a scalable infrastructure. In its initial phases, it will serve national research priorities; over time, it will expand to international collaborations, training opportunities, and joint projects. By combining phenotypic richness with state-of-the-art genomic technologies, the registry will contribute significantly to global efforts aimed at unraveling the biological basis of bipolar disorder.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Konya
      • Konya, Konya, Turkey (Türkiye), 42130
        • Selçuk University Faculty of Medicine, Department of Psychiatry / NeuroPsyBiT-RTSGD Consortium
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

Inclusion Criteria (Bipolar Disorder Cohort):

  • 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.

Inclusion Criteria (Control Cohort):

  • 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.

Exclusion Criteria (applies to both cohorts):

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Successfully Collected and Biobanked DNA Samples
Time Frame: From enrollment to 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completeness of Phenotypic Dataset per Participant
Time Frame: 24 months
Proportion of participants with ≥95% of required variables (demographics, psychiatric history, medication, psychometric scales, metabolic markers, family history) successfully collected via the NeuroCybe Data Collector system.
24 months
Proportion of Biobanked Samples Ready for Genomic/Epigenomic Analysis
Time Frame: 24 months
Proportion of stored samples that meet Illumina Infinium platform quality thresholds (DNA concentration, integrity, and QC metrics) for downstream GWAS/EWAS.
24 months
Rate of Successful Data-Sample Linkage
Time Frame: 24 months
Percentage of participants whose biospecimens are securely linked to their clinical and phenotypic data in the RTSGD on-premises server system, validated by barcoding and audit trail.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selçuk State Hospital

Collaborators

Research and Treatment Society of Genetic Disorders

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

September 8, 2025

First Submitted That Met QC Criteria

September 8, 2025

First Posted (Estimated)

September 15, 2025

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEUROPSYBIT-BD-001
  • TÜBİTAK 1505 (Other Identifier: TÜBİTAK 1505 University-Industry Collaboration Application)
  • RTSGD-BD-BIOBANK-2025 (Other Identifier: RTSGD Internal Project Code)
  • to be updated after approval (Other Identifier: Selçuk University Medical Faculty Ethics Committee Reference Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified (pseudonymised) IPD will be shared for verification/secondary/meta-research under controlled access, per FAIR+GDPR; minimal. Sociodemographics: age (bands), sex/gender, marital, education, SES/employment, region; gravidity/miscarriages; ethnicity where permitted. Clinical: onset age; prior psychiatric history; episode #/polarity; mixed/rapid-cycling/psychosis; hospitalisations; treatment history (dose/duration/levels); family history; suicidality; comorbidities; concomitant meds. Scales: HDRS/HAM-D, YMRS, ALDA, CGI, UKU, FAST, WHOQOL-BREF-TR, PSQI, MEQ-SF, MCTQ, CTQ-53, ASRS, SPS. Lifestyle: tobacco, alcohol, illicit, caffeine; sleep-wake regularity. Labs/biometrics: metabolic-syndrome, BMI, renal/liver, electrolytes, ESR/routine, HR, ECG; QRISK3 (derived score+timepoint only). Biospecimen metadata: type, timepoint, processing, storage, QC; no primary specimens or genomic raw data without approval. Docs: data dictionary/codebook, CRFs, scoring refs, derivation readme.

IPD Sharing 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.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Study Data/Documents

  1. "De-identified clinical, phenotypic, Genotypic Raw, and biospecimen metadata; laboratory quality control metrics; and data dictionaries describing collected variables

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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