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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

Tracking Information
First Submitted Date August 24, 2016
First Posted Date September 2, 2016
Last Update Posted Date January 14, 2020
Study Start Date January 2016
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 1, 2016)
Composite blood based biomarker [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 1, 2016)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Bipolar Illness Onset Study (the BIO Study)
Official Title The Bipolar Illness Onset Study (the BIO Study)
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood Urine Hair
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.
Condition Bipolar Disorder
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 1, 2016)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2026
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
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
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02888262
Other Study ID Numbers Psychiatric Center Copenhagen
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Lars Vedel Kessing, Mental Health Services in the Capital Region, Denmark
Study Sponsor Mental Health Services in the Capital Region, Denmark
Collaborators University of Copenhagen
Investigators
Principal Investigator: Lars V Kessing, Professor Psychiatric Center Copenhagen
PRS Account Mental Health Services in the Capital Region, Denmark
Verification Date January 2020