The Bipolar Illness Onset Study (the BIO Study)

Bipolar Disorder Clinical Trial

— BIO  

Official title:

The Bipolar Illness Onset Study (the BIO Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02888262
• Other study ID #: Psychiatric Center Copenhagen
• Status: Active, not recruiting
• Start date: January 2016
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder

Locations

Country	Name	City	State
Denmark	Psychiatric Center Copenhagen	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite blood based biomarker		5 years
Secondary	Composite smartphone based biomarker including self reported and smartphone generated data	Composite 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	5 years
Secondary	Composite neurocognitive marker including "Cold" and "Hot" cognition.	Composite 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.	5 years