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The Bipolar Illness Onset Study (the BIO Study)

The Bipolar Illness Onset Study (the BIO Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02888262
Acronym
BIO
Enrollment
700
Registered
2016-09-02
Start date
2016-01-31
Completion date
2026-12-31
Last updated
2023-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Bipolar disorder, Blood, Smartphone, Brain imaging, Cognition, Neuropsychology

Brief summary

This longitudinal study aims to identify 1) a composite blood-based biomarker, 2) a composite electronic Smartphone-based biomarker and 3) a neurocognitive signature for bipolar disorder

Detailed description

The study will include 300 patients with newly diagnosed/first episode bipolar disorder, 200 healthy siblings or child family members and 100 healthy individuals without a family history of affective disorder. All individuals will be investigated with repeated blood tests, Smartphone recordings, neuropsychological tests and brain imaging during a five to ten year study period.

Interventions

None listed

Sponsors

University of Copenhagen
CollaboratorOTHER
Mental Health Services in the Capital Region, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Newly diagnosed/first episode bipolar patients, 2. First-generation relatives (siblings and children aged 15 to 40 years) to the recruited newly diagnosed/first episode bipolar patients. 3. Age- and gender matched sample of healthy individuals without a first-generation family history of effective disorders

Exclusion criteria

1. Significant physical disorders 2. Schizophrenia or related disorders

Design outcomes

Primary

MeasureTime frame
Composite blood based biomarker5 years

Secondary

MeasureTime frameDescription
Composite smartphone based biomarker including self reported and smartphone generated data5 yearsComposite smartphone based biomarker including 1) self reported data and 2) smartphone generated data on physical activity 3) social activity and 4) voice features collected during phone calls
Composite neurocognitive marker including Cold and Hot cognition.5 yearsComposite neurocognitive marker including Cold cognition assessed with neuropsychological tests probing verbal memory and executive function and Hot cognition assessed with a comprehensive computerized battery of cognitive tests probing (i) emotional processing (ii) reward processing and (iii) emotional regulation.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026