Clinical trial NCT02888262: The Bipolar Illness Onset Study (the BIO Study)
Official title: The Bipolar Illness Onset Study (the BIO Study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bipolar Disorder
Keywords: Bipolar disorder
Blood
Smartphone
Brain imaging
Cognition
Neuropsychology
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2016-09-02
Enrollment: 700
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Composite blood based biomarker
timeFrame: 5 years
Secondary outcomes:
measure: Composite smartphone based biomarker including self reported and smartphone generated data
timeFrame: 5 years
measure: Composite neurocognitive marker including "Cold" and "Hot" cognition.
timeFrame: 5 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Psychiatric Center Copenhagen
Study officials:
affiliation: Psychiatric Center Copenhagen
name: Lars V Kessing, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.