To Örebro University

Background: Bipolar Disorder (BD) is a severe and heritable psychiatric disorder. It represents a substantial public health problem, due to its prevalence, its high degree of disability and psychiatric and somatic comorbidities, especially cardiometabolic disturbances. Such comorbidities pose a significant additive burden for patients with BD. Considering the clinical heterogeneity of these patients, a better characterization of this population is required to develop personalised treatment approaches.

Objective: BIPCOM is a multicentre study funded by the EU within the ERAperMed Call, involving six centres from different countries (Italy, France, Germany, Norway, Spain, Sweden). The purpose of BIPCOM is to identify somatic comorbidities in BD patients to develop precision medicine approaches.

Aims: BIPCOM aims to define the prevalence rates, risk and protective factors and the natural course of somatic comorbidities of BD patients. Those data will be integrated to develop a tool to support individualized clinical decision-making in BD.

Method: BIPCOM comprises three separate clinical studies to define patient characteristics and a subsequent exploitation element. In the first study, data will be obtained from the Nordic biobanks and medical registries. In the second study, the study centres together will contribute standardized data of at least 1500 patients comprising 24 pre-specified variables (among others past and current comorbidities and treatment). Emphasis will be given to chronic somatic disorders (diabetes mellitus, metabolic syndrome, dyslipidaemia, obesity or endocrine disorders). The third study has a prospective element with in depth characterization of 400 patients including a one-year follow up with a focus on metabolic syndrome. Patients aged from 18 – 65 with a primary diagnosis of BD, who had at least one contact with mental health services in the last year will be included. A “patient schedule” will include each participant’s socio-demographic, clinical and treatment-related data at baseline (T0) and at 1-year follow-up (T1). Five aspects of metabolic syndrome (MetS, waist circumference, triglyceride level, HDL level, blood pressure and fasting glucose) will be determined and subjected to clustering analysis to identify common presentation dynamics. The primary objective of this part is to identify the strongest criteria for the MetS diagnosis at T0 and/orT1 in patients with BD. Moreover, at least 20 patients per site stratified in MetS+ and MetS-, will receive in depth physical activity determinations. For this, patients will be asked to wear accelerometers for one week 3 times a year, to determine physical activity, sedentary time and circadian rhythms. With this data the association between activity and selected clinical markers will be determined. Ultimately, the data of the three studies will be integrated to aid patient care in BD by means of a clinical support tool.

Conclusions: The results of BIPCOM will provide a better understanding of the somatic comorbidities in patients with BD. Focussing especially on MetS the data will help to predict the occurrence of comorbidities to assist physicians in the management of these patients. Ultimately, BIPCOM aims to improve comorbidity management, prevention, early detection and effective treatment of somatic disorders in patients with BD.