The Bipolar Illness Onset Study (the BIO Study)

Active, not recruiting

• Conditions: Bipolar Disorder

• Registration Number: NCT02888262
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-02
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-19
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite blood based biomarker	5 years

Secondary Outcome Measures

Name	Time	Method
Composite smartphone based biomarker including self reported and smartphone generated data	5 years	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
Composite neurocognitive marker including "Cold" and "Hot" cognition.	5 years	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.

Trial Locations

Locations (1)

Psychiatric Center Copenhagen; 🇩🇰 Copenhagen, Denmark