NCT07173842Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 15 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Study type: Observational
Enrollment: 1000 (estimated)
First submitted: 8 Sept 2025
Start date: 1 Oct 2025
Primary completion date: 1 Oct 2027
Lead sponsor: Selçuk State Hospital
Diseases: Bipolar disorder
NCT number: NCT07173842

What you commit to

Study type: Observational
Planned participants: 1000
From 1 Oct 2025 to the primary completion date, 1 Oct 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Blood transfusion within 3 months or blood donation within 2 weeks prior to sampling.

Other illness

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.

Other

Pregnancy or breastfeeding at enrollment.

Who the study is looking for

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.

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Selçuk University Faculty of Medicine, Department of Psychiatry / NeuroPsyBiT-RTSGD Consortium Coordinator of this site? Confirm its status	Konya	Turkey (Türkiye)	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.