Bipolar DisorderBIONCT02888262
The Bipolar Illness Onset Study (the BIO Study)
An observational study of Bipolar Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- How many people
- 700 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Significant physical disorders
- Schizophrenia or related disorders
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorder, Blood, Smartphone, Brain imaging, Cognition, Neuropsychology
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite blood based biomarker
Measured: 5 years
Secondary outcomes (2)
Composite smartphone based biomarker including self reported and smartphone generated data
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
Measured: 5 years
Composite neurocognitive marker including "Cold" and "Hot" cognition.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Lars Vedel Kessing, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Investigators
- Lars V Kessing, Professor, Principal investigator, Psychiatric Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888262
- Sponsor's protocol ID
- Psychiatric Center Copenhagen
- Acronym
- BIO
- Status last verified
- Oct 2023
- First submitted
- 24 Aug 2016
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34083204Stanislaus 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.
PubMed 33135120Stanislaus 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.
PubMed 32839276Melbye 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.
PubMed 32743692Kessing 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.
PubMed 28645967
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bipolar Illness Onset Study (the BIO Study)
- ClinicalTrials.gov ID
- NCT02888262
- Acronym / sponsor ID
- BIO / Psychiatric Center Copenhagen
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar disorder, Blood, Smartphone, Brain imaging, Cognition, Neuropsychology
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Significant physical disorders
- Schizophrenia or related disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite blood based biomarker
Time frame: 5 years
2 secondary outcomes
Composite smartphone based biomarker including self reported and smartphone generated data
Time frame: 5 years
Composite neurocognitive marker including "Cold" and "Hot" cognition.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Derived from this study: PubMed 34083204Stanislaus 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.
- Derived from this study: PubMed 33135120Stanislaus 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.
- Derived from this study: PubMed 32839276Stanislaus 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.
- Derived from this study: PubMed 32743692Melbye 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.
- Derived from this study: PubMed 28645967Kessing 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars V Kessing, Professor principal investigator
Psychiatric Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite blood based biomarker (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02888262, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.