The Bipolar Illness Onset study: research protocol for the BIO cohort study

Lars Vedel Kessing, Klaus Munkholm, Maria Faurholt-Jepsen, Kamilla Woznica Miskowiak, Lars Bo Nielsen, Ruth Frikke-Schmidt, Claus Ekstrøm, Ole Winther, Bente Klarlund Pedersen, Henrik Enghusen Poulsen, Roger S McIntyre, Flavio Kapczinski, Wagner F Gattaz, Jakob Bardram, Mads Frost, Oscar Mayora, Gitte Moos Knudsen, Mary Phillips, Maj Vinberg, Lars Vedel Kessing, Klaus Munkholm, Maria Faurholt-Jepsen, Kamilla Woznica Miskowiak, Lars Bo Nielsen, Ruth Frikke-Schmidt, Claus Ekstrøm, Ole Winther, Bente Klarlund Pedersen, Henrik Enghusen Poulsen, Roger S McIntyre, Flavio Kapczinski, Wagner F Gattaz, Jakob Bardram, Mads Frost, Oscar Mayora, Gitte Moos Knudsen, Mary Phillips, Maj Vinberg

Abstract

Introduction: Bipolar disorder is an often disabling mental illness with a lifetime prevalence of 1%-2%, 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 5-10 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.

Keywords: Depression and mood disorders; MRI scanning; biomarker; bipolar disorder; cognition; smartphone.

Conflict of interest statement

Competing interests: LVK has within the preceding three years been a consultant for Lundbeck, AstraZeneca and Sunovion. KWM has received consultancy fees in the past three years from Lundbeck and Allergan. MFJ has been a consultant for Eli-Lilly and Lundbeck. MV has within the preceding three years been a consultant for AstraZeneca and Servier. FK has been a speaker for Ache, Daiichi Sankyoand Janssen. MP is a consultant for Roche Pharmaceuticals. RSM: Advisory boards: Lundbeck, Pfizer, AstraZeneca, Eli-Lilly, Janssen, Ortho Purdue, Johnson & Johnson, Moksha8, Sunovion, Mitsubishi, Takeda, Forest, Otsuka, Bristol-Myers Squibb, Shire. Speaker fees: Lundbeck, Pfizer, AstraZeneca, Eli-Lilly, Janssen Ortho, Purdue, Johnson & Johnson, Moksha8, Sunovion, Mitsubishi, Takeda, Forest, Otsuka, Bristol-Myers Squibb, Shire. Research grants: Lundbeck, Janssen Ortho, Shire, Purdue, AstraZeneca, Pfizer, Otsuka, Allergan. HEP has received a research grant from Boehringer Ingelheim. GMK has received honoraria as Field Editor of the International Journal of Neuropsychopharmacology and as scientific advisor for H Lundbeck A/S. JB and MF are co-founders and shareholders in Monsenso. LBN, RFS and WFG declare no competing interests. The validity of the research cannot be influenced by any of these potential secondary interests (such as financial gain or personal relationship).

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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