101. The Bipolar Illness Onset study:research protocol for the BIO cohort study
- Author
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Oscar Mayora, Henrik E. Poulsen, Claus Thorn Ekstrøm, Maj Vinberg, Bente Klarlund Pedersen, Flávio Kapczinski, Roger S. McIntyre, Lars Vedel Kessing, Ole Winther, Gitte M. Knudsen, Mary L. Phillips, Ruth Frikke-Schmidt, Wagner F. Gattaz, Jakob E. Bardram, Kamilla W. Miskowiak, Mads Frost, Lars Bo Nielsen, Maria Faurholt-Jepsen, and Klaus Munkholm
- Subjects
Male ,cognition ,Bipolar Disorder ,Denmark ,Neuropsychological Tests ,smartphone ,Severity of Illness Index ,0302 clinical medicine ,Depression and mood disorders ,Recurrence ,Protocol ,Medicine ,Longitudinal Studies ,bipolar disorder ,Depression ,General Medicine ,Middle Aged ,3. Good health ,Diagnostic and Statistical Manual of Mental Disorders ,Mental Health ,Research Design ,Regression Analysis ,biomarker ,Female ,Biological psychiatry ,medicine.symptom ,Mania ,Cohort study ,Adult ,medicine.medical_specialty ,Adolescent ,Neuroimaging ,Young Adult ,03 medical and health sciences ,Prevalence of mental disorders ,SDG 3 - Good Health and Well-being ,Severity of illness ,Humans ,Bipolar disorder ,Psychiatry ,Aged ,Psychiatric Status Rating Scales ,business.industry ,Siblings ,ESTUDOS DE COORTES ,Mental illness ,medicine.disease ,030227 psychiatry ,MRI scanning ,Case-Control Studies ,business ,Neurocognitive ,Biomarkers ,030217 neurology & neurosurgery - Abstract
Introduction Bipolar disorder is an often disabling mental illness with a lifetime prevalence of 1textendash2 a high risk of recurrence of manic and depressive episodes, a lifelong elevated risk of suicide and a substantial heritability. The course of illness is frequently characterised by progressive shortening of interepisode intervals with each recurrence and increasing cognitive dysfunction in a subset of individuals with this condition. Clinically, diagnostic boundaries between bipolar disorder and other psychiatric disorders such as unipolar depression are unclear although pharmacological and psychological treatment strategies differ substantially. Patients with bipolar disorder are often misdiagnosed and the mean delay between onset and diagnosis is 5textendash10 years. Although the risk of relapse of depression and mania is high it is for most patients impossible to predict and consequently prevent upcoming episodes in an individual tailored way. The identification of objective biomarkers can both inform bipolar disorder diagnosis and provide biological targets for the development of new and personalised treatments. Accurate diagnosis of bipolar disorder in its early stages could help prevent the long-term detrimental effects of the illness.The present Bipolar Illness Onset study aims to identify (1) a composite blood-based biomarker, (2) a composite electronic smartphone-based biomarker and (3) a neurocognitive and neuroimaging-based signature for bipolar disorder.Methods and analysis The study will include 300 patients with newly diagnosed/first-episode bipolar disorder, 200 of their healthy siblings or offspring and 100 healthy individuals without a family history of affective disorder. All participants will be followed longitudinally with repeated blood samples and other biological tissues, self-monitored and automatically generated smartphone data, neuropsychological tests and a subset of the cohort with neuroimaging during a 5 to 10-year study period.Ethics and dissemination The study has been approved by the Local Ethical Committee (H-7-2014-007) and the data agency, Capital Region of Copenhagen (RHP-2015-023), and the findings will be widely disseminated at international conferences and meetings including conferences for the International Society for Bipolar Disorders and the World Federation of Societies for Biological Psychiatry and in scientific peer-reviewed papers.Trial registration number NCT02888262.
- Published
- 2017