RT Journal Article
SR Electronic
T1 The Bipolar Illness Onset study: research protocol for the BIO cohort study
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e015462
DO 10.1136/bmjopen-2016-015462
VO 7
IS 6
A1 Lars Vedel Kessing
A1 Klaus Munkholm
A1 Maria Faurholt-Jepsen
A1 Kamilla Woznica Miskowiak
A1 Lars Bo Nielsen
A1 Ruth Frikke-Schmidt
A1 Claus Ekstrøm
A1 Ole Winther
A1 Bente Klarlund Pedersen
A1 Henrik Enghusen Poulsen
A1 Roger S McIntyre
A1 Flavio Kapczinski
A1 Wagner F Gattaz
A1 Jakob Bardram
A1 Mads Frost
A1 Oscar Mayora
A1 Gitte Moos Knudsen
A1 Mary Phillips
A1 Maj Vinberg
YR 2017
UL http://bmjopen.bmj.com/content/7/6/e015462.abstract
AB 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.