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The Bipolar Illness Onset Study (the BIO Study) | Clinical Trials | Clareo Health

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Active Not RecruitingNCT02888262

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

Lead sponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Collaborators

University of Copenhagen

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.

Age

16 - No limit years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 19, 2023Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

Phase—

Enrollment700

Start dateJan 2016

Last updatedOct 19, 2023

Condition

Bipolar Disorder

Locations shown

Psychiatric Center Copenhagen

Copenhagen

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 19, 2023Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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