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Active, Not Recruiting

NCT Number: NCT02888262

The Bipolar Illness Onset Study (the BIO Study)

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Psychiatric Center Copenhagen

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Significant physical disorders
  • Schizophrenia or related disorders

Treatment and study plan

Primary outcomes

  1. Composite blood based biomarker

    Time frame: 5 years

Secondary outcomes

  1. Composite smartphone based biomarker including self reported and smartphone generated data

    Time frame: 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

  2. Composite neurocognitive marker including "Cold" and "Hot" cognition.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Acronym: BIO

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2016
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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