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The Bipolar Illness Onset Study (the BIO Study)

M

Mental Health Services in the Capital Region, Denmark

Status

Active, not recruiting

Conditions

Bipolar Disorder

Study type

Observational

Funder types

Other

Identifiers

NCT02888262
Psychiatric Center Copenhagen

Details and patient eligibility

About

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

Full 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.

Enrollment

700 patients

Sex

All

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

700 participants in 3 patient groups

Patients with bipolar disorder
Description:
Patients with newly diagnosed bipolar disorder
Healthy first generation relatives
Description:
Healthy first generation relatives to the included patients
Healthy individuals
Description:
Healthy individuals without a family history of psychiatric disorders

Trial contacts and locations

1

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Central trial contact

Marianne Meinertz; Lars V Kessing, Professor

Data sourced from clinicaltrials.gov

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