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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 : January 14, 2020
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Lars Vedel Kessing, Mental Health Services in the Capital Region, Denmark

Study Description
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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

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Bipolar Illness Onset Study (the BIO Study)
Study Start Date : January 2016
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Groups and Cohorts
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Group/Cohort
Patients with bipolar disorder
Patients with newly diagnosed bipolar disorder
Healthy first generation relatives
Healthy first generation relatives to the included patients
Healthy individuals
Healthy individuals without a family history of psychiatric disorders


Outcome Measures
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Primary Outcome Measures :
  1. Composite blood based biomarker [ Time Frame: 5 years ]

Secondary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Blood Urine Hair

Eligibility Criteria
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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
Study Population
  1. 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.
  2. 200 first-generation relatives (siblings and children aged 15 to 40 years) to the recruited newly diagnosed/first episode bipolar patients.
  3. 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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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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

Locations
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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   
Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
University of Copenhagen
Investigators
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Principal Investigator: Lars V Kessing, Professor Psychiatric Center Copenhagen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lars Vedel Kessing, Mental Health Services in the Capital Region, Denmark:
Bipolar disorder
Blood
Smartphone
 Brain imaging
Cognition
Neuropsychology
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders