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Biobank Collecting Health Data and Blood Samples From People With Bipolar Disorder

Builds a biobank of health information and blood samples from people with bipolar disorder.

Key facts

Who runs it
Selçuk State Hospital
Where
Konya, TürkiyeSee the site
Trial code
Registry title
NeuroPsyBiT-BD Omics: Genomic & Epigenomic Biobank of Bipolar Disorder
Status
Not yet recruiting
People taking part
1,000 people, planned
Started
1 Oct 2025
Expected to end
1 Oct 2027
Type of study
Observational, 2 groups
Treatments tested
  • Biobanking and Phenotypic Data Collection
Record updated
15 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with bipolar disorder, and also healthy adults with no psychiatric illness as a control group. Everyone gives a blood sample and answers standard questionnaires for a research biobank.

Age
18 to 65 years
Sex
All sexes can join
Disease stage
Bipolar I, II or NOS (not otherwise specified), confirmed by a structured interview (SCID-5). Healthy controls must have no lifetime psychiatric disorder.
Earlier treatment
People with bipolar disorder must be on a stable psychotropic medicine for at least 14 days before sampling, or drug-free for at least 14 days. Controls must not take any psychotropic medicine now.

Main reasons for not taking part

  • Neurological disorders such as epilepsy, multiple sclerosis or Parkinson's disease
  • Severe, uncontrolled medical illness
  • Current substance use disorder
  • Pregnancy or breastfeeding
  • Acute mania or psychosis that needs immediate hospital care

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Blood transfusion within 3 months or blood donation within 2 weeks prior to sampling
  • 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
  • Current substance use disorder
  • 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
  • Pregnancy or breastfeeding at enrollment

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in Türkiye

  • Selçuk University Faculty of Medicine, Department of Psychiatry / NeuroPsyBiT-RTSGD ConsortiumKonya, TürkiyeContact: Rukiye Tekdemir, MD.No longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • 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.

    Treatment: 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.

    Treatment: Biobanking and Phenotypic Data Collection

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Biobank Collecting Health Data and Blood Samples From People With Bipolar DisorderGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07173842, who can take part
Record updated
15 September 2025