Status:
NOT_YET_RECRUITING
NeuroPsyBiT-BD Omics: Genomic & Epigenomic Biobank of Bipolar Disorder
Lead Sponsor:
Selçuk State Hospital
Collaborating Sponsors:
Research and Treatment Society of Genetic Disorders
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
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 prospe...
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 p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT07173842
Start Date
October 1 2025
End Date
October 1 2027
Last Update
September 15 2025
Active Locations (1)
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1
Selçuk University Faculty of Medicine, Department of Psychiatry / NeuroPsyBiT-RTSGD Consortium
Konya, Konya, Turkey (Türkiye), 42130