The Bipolar Illness Onset Study (the BIO Study)

NCT02888262 | Active Not Recruiting

• 1 other identifier: Psychiatric Center Copenhagen
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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

Conditions

Bipolar Disorder

Keywords

Bipolar disorder; Blood; Smartphone; Brain imaging; Cognition; Neuropsychology

Outcome Measures

Primary Outcomes (1)

• Composite blood based biomarker

  5 years

Secondary Outcomes (2)

• Composite smartphone based biomarker including self reported and smartphone generated data

  5 years

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

  5 years

Study Arms (3)

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Significant physical disorders
• Schizophrenia or related disorders

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Psychiatric Center Copenhagen

Copenhagen, 2100, Denmark

Location

Related Publications (5)

• Stanislaus S, Coello K, Kjaerstad HL, Sletved KSO, Seeberg I, Frost M, Bardram JE, Jensen RN, Vinberg M, Faurholt-Jepsen M, Kessing LV. Prevalences of comorbid anxiety disorder and daily smartphone-based self-reported anxiety in patients with newly diagnosed bipolar disorder. Evid Based Ment Health. 2021 Nov;24(4):137-144. doi: 10.1136/ebmental-2021-300259. Epub 2021 Jun 3.

  PMID: 34083204 DERIVED

• Stanislaus S, Vinberg M, Melbye S, Frost M, Busk J, Bardram JE, Kessing LV, Faurholt-Jepsen M. Smartphone-based activity measurements in patients with newly diagnosed bipolar disorder, unaffected relatives and control individuals. Int J Bipolar Disord. 2020 Nov 2;8(1):32. doi: 10.1186/s40345-020-00195-0.

  PMID: 33135120 DERIVED

• Stanislaus S, Vinberg M, Melbye S, Frost M, Busk J, Bardram JE, Faurholt-Jepsen M, Kessing LV. Daily self-reported and automatically generated smartphone-based sleep measurements in patients with newly diagnosed bipolar disorder, unaffected first-degree relatives and healthy control individuals. Evid Based Ment Health. 2020 Nov;23(4):146-153. doi: 10.1136/ebmental-2020-300148. Epub 2020 Aug 24.

  PMID: 32839276 DERIVED

• Melbye SA, Stanislaus S, Vinberg M, Frost M, Bardram JE, Sletved K, Coello K, Kjaerstad HL, Christensen EM, Faurholt-Jepsen M, Kessing LV. Mood, activity, and sleep measured via daily smartphone-based self-monitoring in young patients with newly diagnosed bipolar disorder, their unaffected relatives and healthy control individuals. Eur Child Adolesc Psychiatry. 2021 Aug;30(8):1209-1221. doi: 10.1007/s00787-020-01611-7. Epub 2020 Aug 2.

  PMID: 32743692 DERIVED

• Kessing LV, Munkholm K, Faurholt-Jepsen M, Miskowiak KW, Nielsen LB, Frikke-Schmidt R, Ekstrom C, Winther O, Pedersen BK, Poulsen HE, McIntyre RS, Kapczinski F, Gattaz WF, Bardram J, Frost M, Mayora O, Knudsen GM, Phillips M, Vinberg M. The Bipolar Illness Onset study: research protocol for the BIO cohort study. BMJ Open. 2017 Jun 23;7(6):e015462. doi: 10.1136/bmjopen-2016-015462.

  PMID: 28645967 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood Urine Hair

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Lars V Kessing, Professor

  Psychiatric Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, DMSc.

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 2, 2016
• Study Start: January 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)