The Bipolar Illness Onset Study (the BIO Study) (BIO)
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ClinicalTrials.gov Identifier: NCT02888262 |
Recruitment Status :
Recruiting
First Posted : September 2, 2016
Last Update Posted : April 8, 2022
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Condition or disease |
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Bipolar Disorder |
Study Type : | Observational |
Estimated Enrollment : | 600 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Bipolar Illness Onset Study (the BIO Study) |
Actual Study Start Date : | January 2016 |
Estimated Primary Completion Date : | December 2026 |
Estimated Study Completion Date : | December 2026 |

Group/Cohort |
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Patients with bipolar disorder
Patients with newly diagnosed bipolar disorder
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Healthy first generation relatives
Healthy first generation relatives to the included patients
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Healthy individuals
Healthy individuals without a family history of psychiatric disorders
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- Composite blood based biomarker [ Time Frame: 5 years ]
- 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
- 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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
- 300 patients referred to the Copenhagen Affective Disorder Clinic as newly diagnosed/first episode bipolar patients, i.e., onset of first manic or hypomanic episode or when the diagnosis of bipolar disorder is made for the first time.
- 200 first-generation relatives (siblings and children aged 15 to 40 years) to the recruited newly diagnosed/first episode bipolar patients.
- 100 age-, gender- and IQ-matched sample of healthy individuals without a first-generation family history of affective disorders recruited among blood donors from the Blood Bank at Rigshospitalet, Copenhagen, as in prior studies.
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888262
Contact: Lars V Kessing, Professor | 38647081 ext 0045 | lars.vedel.kessing@regionh.dk | |
Contact: Marianne Meinertz | 38 64 00 96 ext 0045 | Marianne.Meinertz@regionh.dk |
Denmark | |
Psychiatric Center Copenhagen | Recruiting |
Copenhagen, Denmark, 2100 | |
Contact: Lars V Kessing, Professor 38647081 ext 0045 lars.vedel.kessing@regionh.dk | |
Contact: Marianne Meinertz 38 64 00 96 ext 0045 Marianne.Meinertz@regionh.dk |
Principal Investigator: | Lars V Kessing, Professor | Psychiatric Center Copenhagen |
Responsible Party: | Lars Vedel Kessing, Professor, MD, DMSc., Mental Health Services in the Capital Region, Denmark |
ClinicalTrials.gov Identifier: | NCT02888262 |
Other Study ID Numbers: |
Psychiatric Center Copenhagen |
First Posted: | September 2, 2016 Key Record Dates |
Last Update Posted: | April 8, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Bipolar disorder Blood Smartphone |
Brain imaging Cognition Neuropsychology |
Bipolar Disorder Bipolar and Related Disorders Mental Disorders |