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

See Contacts and Locations

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

Composite blood based biomarker [ Time Frame: 5 years ]

Original Primary Outcome Measures

Same as current

Change History

Current Secondary Outcome Measures

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

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.
200 first-generation relatives (siblings and children aged 15 to 40 years) to the recruited newly diagnosed/first episode bipolar patients.
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

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:

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

Exclusion Criteria:

Significant physical disorders
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

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Plan to Share IPD:

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

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