Bipolar DisorderNeuroPsyBiT-BDNCT07173842
NeuroPsyBiT-BD Omics: Genomic & Epigenomic Biobank of Bipolar Disorder
An observational study of Bipolar Disorder, run by Selçuk State Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Biobanking and Phenotypic Data Collection
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 1 Oct 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Selçuk University Faculty of Medicine, Department of Psychiatry / NeuroPsyBiT-RTSGD Consortium
Konya, Konya, 42130
Rukiye Tekdemir, MD., +90 530 326 49 95, rukiye.tekdemir@selcuk.edı.tr
About this study
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
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:
Read more
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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- Biobanking and Phenotypic Data Collection
- Keywords
- Bipolar Disorder, Mood Disorders, Psychiatric Genetics, Epigenomics, GWAS, EWAS, Biobank, Phenotyping
- Medical subject headings
- Bipolar Disorder, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biobanking and Phenotypic Data CollectionOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Biobanking and Phenotypic Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to 24 months
Secondary outcomes (3)
Completeness of Phenotypic Dataset per Participant
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.
Measured: 24 months
Proportion of Biobanked Samples Ready for Genomic/Epigenomic Analysis
Proportion of stored samples that meet Illumina Infinium platform quality thresholds (DNA concentration, integrity, and QC metrics) for downstream GWAS/EWAS.
Measured: 24 months
Rate of Successful Data-Sample Linkage
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Selçuk State Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Research and Treatment Society of Genetic Disorders
- Responsible party
- Principal investigator, Rukiye Tekdemir, Selçuk State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173842
- Sponsor's protocol ID
- NEUROPSYBIT-BD-001
- Other IDs
- TÜBİTAK 1505, RTSGD-BD-BIOBANK-2025, to be updated after approval
- Acronym
- NeuroPsyBiT-BD
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Marovic B, Curcin V. Impact of the European General Data Protection Regulation (GDPR) on Health Data Management in a European Union Candidate Country: A Case Study of Serbia. JMIR Med Inform. 2020 Apr 17;8(4):e14604. doi: 10.2196/14604.
PubMed 32301736Molnar-Gabor F, Beauvais MJS, Bernier A, Jimenez MPN, Recuero M, Knoppers BM. Bridging the European Data Sharing Divide in Genomic Science. J Med Internet Res. 2022 Oct 19;24(10):e37236. doi: 10.2196/37236.
PubMed 36260387Talu CK, Toper MH, Sahin Y, Erdogdu IH. Pathology and Biobanking. Turk Patoloji Derg. 2020;36(2):93-108. doi: 10.5146/tjpath.2020.01482.
PubMed 32189322Bernier A, Molnar-Gabor F, Knoppers BM, Borry P, Cesar PMDG, Devriendt T, Goisauf M, Murtagh M, Jimenez PN, Recuero M, Rial-Sebbag E, Shabani M, Wilson RC, Zaccagnini D, Maxwell L. Reconciling the biomedical data commons and the GDPR: three lessons from the EUCAN ELSI collaboratory. Eur J Hum Genet. 2024 Jan;32(1):69-76. doi: 10.1038/s41431-023-01403-y. Epub 2023 Jun 15.
PubMed 37322132Owusu SA. Ethical implications of the widespread use of informal mHealth methods in Ghana. J Med Ethics. 2024 Jul 23;50(8):563-568. doi: 10.1136/medethics-2021-107920.
PubMed 35396337Yakubu A, Munung NS, De Vries J. How Should Biobanking Be Governed in Low-Resource Settings? AMA J Ethics. 2020 Feb 1;22(2):E156-163. doi: 10.1001/amajethics.2020.156.
PubMed 32048586Kilkku N, Halkoaho A. Informed consent, genomic research and mental health: A integrative review. Nurs Ethics. 2022 Jun;29(4):973-987. doi: 10.1177/09697330211066573. Epub 2022 Feb 4.
PubMed 35119339Campbell LD, Astrin JJ, DeSouza Y, Giri J, Patel AA, Rawley-Payne M, Rush A, Sieffert N. The 2018 Revision of the ISBER Best Practices: Summary of Changes and the Editorial Team's Development Process. Biopreserv Biobank. 2018 Feb;16(1):3-6. doi: 10.1089/bio.2018.0001. Epub 2018 Feb 2.
PubMed 29393664Akyuz K, Goisauf M, Martin GM, Mayrhofer MT, Antoniou S, Charalambidou G, Deltas C, Malatras A, Papagregoriou G, Stefanou C, Voutounou M. Risk mapping for better governance in biobanking: the case of biobank.cy. Front Genet. 2024 Jun 14;15:1397156. doi: 10.3389/fgene.2024.1397156. eCollection 2024.
PubMed 38948356Ochang P, Stahl BC, Eke D. The ethical and legal landscape of brain data governance. PLoS One. 2022 Dec 29;17(12):e0273473. doi: 10.1371/journal.pone.0273473. eCollection 2022.
PubMed 36580464Eke DO, Bernard A, Bjaalie JG, Chavarriaga R, Hanakawa T, Hannan AJ, Hill SL, Martone ME, McMahon A, Ruebel O, Crook S, Thiels E, Pestilli F. International data governance for neuroscience. Neuron. 2022 Feb 16;110(4):600-612. doi: 10.1016/j.neuron.2021.11.017. Epub 2021 Dec 15.
PubMed 34914921Pisanu C, Meloni A, Severino G, Squassina A. Genetic and Epigenetic Markers of Lithium Response. Int J Mol Sci. 2022 Jan 29;23(3):1555. doi: 10.3390/ijms23031555.
PubMed 35163479Muneer A. The Discovery of Clinically Applicable Biomarkers for Bipolar Disorder: A Review of Candidate and Proteomic Approaches. Chonnam Med J. 2020 Sep;56(3):166-179. doi: 10.4068/cmj.2020.56.3.166. Epub 2020 Sep 24.
PubMed 33014755Legrand A, Iftimovici A, Khayachi A, Chaumette B. Epigenetics in bipolar disorder: a critical review of the literature. Psychiatr Genet. 2021 Feb 1;31(1):1-12. doi: 10.1097/YPG.0000000000000267.
PubMed 33290382Mullins N, Forstner AJ, O'Connell KS, Coombes B, Coleman JRI, Qiao Z, Als TD, Bigdeli TB, Borte S, Bryois J, Charney AW, Drange OK, Gandal MJ, Hagenaars SP, Ikeda M, Kamitaki N, Kim M, Krebs K, Panagiotaropoulou G, Schilder BM, Sloofman LG, Steinberg S, Trubetskoy V, Winsvold BS, Won HH, Abramova L, Adorjan K, Agerbo E, Al Eissa M, Albani D, Alliey-Rodriguez N, Anjorin A, Antilla V, Antoniou A, Awasthi S, Baek JH, Baekvad-Hansen M, Bass N, Bauer M, Beins EC, Bergen SE, Birner A, Bocker Pedersen C, Boen E, Boks MP, Bosch R, Brum M, Brumpton BM, Brunkhorst-Kanaan N, Budde M, Bybjerg-Grauholm J, Byerley W, Cairns M, Casas M, Cervantes P, Clarke TK, Cruceanu C, Cuellar-Barboza A, Cunningham J, Curtis D, Czerski PM, Dale AM, Dalkner N, David FS, Degenhardt F, Djurovic S, Dobbyn AL, Douzenis A, Elvsashagen T, Escott-Price V, Ferrier IN, Fiorentino A, Foroud TM, Forty L, Frank J, Frei O, Freimer NB, Frisen L, Gade K, Garnham J, Gelernter J, Giortz Pedersen M, Gizer IR, Gordon SD, Gordon-Smith K, Greenwood TA, Grove J, Guzman-Parra J, Ha K, Haraldsson M, Hautzinger M, Heilbronner U, Hellgren D, Herms S, Hoffmann P, Holmans PA, Huckins L, Jamain S, Johnson JS, Kalman JL, Kamatani Y, Kennedy JL, Kittel-Schneider S, Knowles JA, Kogevinas M, Koromina M, Kranz TM, Kranzler HR, Kubo M, Kupka R, Kushner SA, Lavebratt C, Lawrence J, Leber M, Lee HJ, Lee PH, Levy SE, Lewis C, Liao C, Lucae S, Lundberg M, MacIntyre DJ, Magnusson SH, Maier W, Maihofer A, Malaspina D, Maratou E, Martinsson L, Mattheisen M, McCarroll SA, McGregor NW, McGuffin P, McKay JD, Medeiros H, Medland SE, Millischer V, Montgomery GW, Moran JL, Morris DW, Muhleisen TW, O'Brien N, O'Donovan C, Olde Loohuis LM, Oruc L, Papiol S, Pardinas AF, Perry A, Pfennig A, Porichi E, Potash JB, Quested D, Raj T, Rapaport MH, DePaulo JR, Regeer EJ, Rice JP, Rivas F, Rivera M, Roth J, Roussos P, Ruderfer DM, Sanchez-Mora C, Schulte EC, Senner F, Sharp S, Shilling PD, Sigurdsson E, Sirignano L, Slaney C, Smeland OB, Smith DJ, Sobell JL, Soholm Hansen C, Soler Artigas M, Spijker AT, Stein DJ, Strauss JS, Swiatkowska B, Terao C, Thorgeirsson TE, Toma C, Tooney P, Tsermpini EE, Vawter MP, Vedder H, Walters JTR, Witt SH, Xi S, Xu W, Yang JMK, Young AH, Young H, Zandi PP, Zhou H, Zillich L; HUNT All-In Psychiatry; Adolfsson R, Agartz I, Alda M, Alfredsson L, Babadjanova G, Backlund L, Baune BT, Bellivier F, Bengesser S, Berrettini WH, Blackwood DHR, Boehnke M, Borglum AD, Breen G, Carr VJ, Catts S, Corvin A, Craddock N, Dannlowski U, Dikeos D, Esko T, Etain B, Ferentinos P, Frye M, Fullerton JM, Gawlik M, Gershon ES, Goes FS, Green MJ, Grigoroiu-Serbanescu M, Hauser J, Henskens F, Hillert J, Hong KS, Hougaard DM, Hultman CM, Hveem K, Iwata N, Jablensky AV, Jones I, Jones LA, Kahn RS, Kelsoe JR, Kirov G, Landen M, Leboyer M, Lewis CM, Li QS, Lissowska J, Lochner C, Loughland C, Martin NG, Mathews CA, Mayoral F, McElroy SL, McIntosh AM, McMahon FJ, Melle I, Michie P, Milani L, Mitchell PB, Morken G, Mors O, Mortensen PB, Mowry B, Muller-Myhsok B, Myers RM, Neale BM, Nievergelt CM, Nordentoft M, Nothen MM, O'Donovan MC, Oedegaard KJ, Olsson T, Owen MJ, Paciga SA, Pantelis C, Pato C, Pato MT, Patrinos GP, Perlis RH, Posthuma D, Ramos-Quiroga JA, Reif A, Reininghaus EZ, Ribases M, Rietschel M, Ripke S, Rouleau GA, Saito T, Schall U, Schalling M, Schofield PR, Schulze TG, Scott LJ, Scott RJ, Serretti A, Shannon Weickert C, Smoller JW, Stefansson H, Stefansson K, Stordal E, Streit F, Sullivan PF, Turecki G, Vaaler AE, Vieta E, Vincent JB, Waldman ID, Weickert TW, Werge T, Wray NR, Zwart JA, Biernacka JM, Nurnberger JI, Cichon S, Edenberg HJ, Stahl EA, McQuillin A, Di Florio A, Ophoff RA, Andreassen OA. Genome-wide association study of more than 40,000 bipolar disorder cases provides new insights into the underlying biology. Nat Genet. 2021 Jun;53(6):817-829. doi: 10.1038/s41588-021-00857-4. Epub 2021 May 17.
PubMed 34002096
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07173842
- Acronym / sponsor ID
- NeuroPsyBiT-BD / NEUROPSYBIT-BD-001
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Mood Disorders, Psychiatric Genetics, Epigenomics, GWAS, EWAS, Biobank, Phenotyping
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Selçuk State HospitalUniversity, hospital or other
- Collaborators
- Research and Treatment Society of Genetic Disorders
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar Disorder Patients | – | Other: Biobanking and Phenotypic Data CollectionParticipants 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. |
| Control Group | – | Other: Biobanking and Phenotypic Data CollectionHealthy 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biobanking and Phenotypic Data CollectionThis 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. | Other | Bipolar Disorder Patients, Control Group |
Primary outcome
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
3 secondary outcomes
Completeness of Phenotypic Dataset per Participant
Time frame: 24 months
Proportion of Biobanked Samples Ready for Genomic/Epigenomic Analysis
Time frame: 24 months
Rate of Successful Data-Sample Linkage
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 32301736Marovic B, Curcin V. Impact of the European General Data Protection Regulation (GDPR) on Health Data Management in a European Union Candidate Country: A Case Study of Serbia. JMIR Med Inform. 2020 Apr 17;8(4):e14604. doi: 10.2196/14604.
- Background: PubMed 36260387Molnar-Gabor F, Beauvais MJS, Bernier A, Jimenez MPN, Recuero M, Knoppers BM. Bridging the European Data Sharing Divide in Genomic Science. J Med Internet Res. 2022 Oct 19;24(10):e37236. doi: 10.2196/37236.
- Background: PubMed 32189322Talu CK, Toper MH, Sahin Y, Erdogdu IH. Pathology and Biobanking. Turk Patoloji Derg. 2020;36(2):93-108. doi: 10.5146/tjpath.2020.01482.
- Background: PubMed 37322132Bernier A, Molnar-Gabor F, Knoppers BM, Borry P, Cesar PMDG, Devriendt T, Goisauf M, Murtagh M, Jimenez PN, Recuero M, Rial-Sebbag E, Shabani M, Wilson RC, Zaccagnini D, Maxwell L. Reconciling the biomedical data commons and the GDPR: three lessons from the EUCAN ELSI collaboratory. Eur J Hum Genet. 2024 Jan;32(1):69-76. doi: 10.1038/s41431-023-01403-y. Epub 2023 Jun 15.
- Background: PubMed 35396337Owusu SA. Ethical implications of the widespread use of informal mHealth methods in Ghana. J Med Ethics. 2024 Jul 23;50(8):563-568. doi: 10.1136/medethics-2021-107920.
- Background: PubMed 32048586Yakubu A, Munung NS, De Vries J. How Should Biobanking Be Governed in Low-Resource Settings? AMA J Ethics. 2020 Feb 1;22(2):E156-163. doi: 10.1001/amajethics.2020.156.
- Background: PubMed 35119339Kilkku N, Halkoaho A. Informed consent, genomic research and mental health: A integrative review. Nurs Ethics. 2022 Jun;29(4):973-987. doi: 10.1177/09697330211066573. Epub 2022 Feb 4.
- Background: PubMed 29393664Campbell LD, Astrin JJ, DeSouza Y, Giri J, Patel AA, Rawley-Payne M, Rush A, Sieffert N. The 2018 Revision of the ISBER Best Practices: Summary of Changes and the Editorial Team's Development Process. Biopreserv Biobank. 2018 Feb;16(1):3-6. doi: 10.1089/bio.2018.0001. Epub 2018 Feb 2.
- Background: PubMed 38948356Akyuz K, Goisauf M, Martin GM, Mayrhofer MT, Antoniou S, Charalambidou G, Deltas C, Malatras A, Papagregoriou G, Stefanou C, Voutounou M. Risk mapping for better governance in biobanking: the case of biobank.cy. Front Genet. 2024 Jun 14;15:1397156. doi: 10.3389/fgene.2024.1397156. eCollection 2024.
- Background: PubMed 36580464Ochang P, Stahl BC, Eke D. The ethical and legal landscape of brain data governance. PLoS One. 2022 Dec 29;17(12):e0273473. doi: 10.1371/journal.pone.0273473. eCollection 2022.
- Background: PubMed 34914921Eke DO, Bernard A, Bjaalie JG, Chavarriaga R, Hanakawa T, Hannan AJ, Hill SL, Martone ME, McMahon A, Ruebel O, Crook S, Thiels E, Pestilli F. International data governance for neuroscience. Neuron. 2022 Feb 16;110(4):600-612. doi: 10.1016/j.neuron.2021.11.017. Epub 2021 Dec 15.
- Background: PubMed 35163479Pisanu C, Meloni A, Severino G, Squassina A. Genetic and Epigenetic Markers of Lithium Response. Int J Mol Sci. 2022 Jan 29;23(3):1555. doi: 10.3390/ijms23031555.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Selçuk State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Torabi, MD., Phd. (+90 552 304 2215, ali.torabi@rtsgd.org.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Successfully Collected and Biobanked DNA Samples (time frame: From enrollment to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07173842, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.