The BiFOUR group is collaborating on research projects examining diverse but complementary aspects of bipolar disorder (BD). Common to the group's projects is the integration of smartphone-based technologies, enabling careful and fine-grained monitoring of variations in mood. Currently, the group is carrying out large scale clinical trials on anti-inflammatory augmentation with Aspirin, sexual functioning across affective phases, psychoeducation of close relatives to BD patients, and novel biomarkers suitable for differentiating unipolar from bipolar depression:
The A-bipolar RCT: Effects of low-dose Aspirin in bipolar disorder – a randomized controlled trial.
BD is increasingly conceived as a multisystem disorder with inflammation confirmed to be involved in the pathogenesis. Emerging yet compelling data converge to suggest that low-dose Aspirin may protect against its onset and deterioration. The present study is the first double-blinded randomized placebo-controlled trial investigating whether low-dose Aspirin versus placebo as add-on to standard treatment improves mood stabilization and other critical patient outcomes in 250 subjects with BD, and whether its principal effects are antimanic, antidepressant or prophylactic against relapse.
The R-Bipolar RCT: Group-based psychoeducation for Relatives to patients with bipolar disorder – a large scale real world randomized controlled trial.
Relatives of patients with BD often experience emotional burden with depressive symptoms and stress that again increases the likelihood of destabilization and relapses in the patient. In relation to relatives and caregivers of patients with BD, effects of group-based psychoeducation have been scarcely investigated. In a large-scale real-world randomized controlled trial, we will test whether group-based psychoeducation for 250 relatives to patients with BD improves mood instability and other critical outcomes in relatives as well as the corresponding patients with BD.
The BIDISEX Project:
BD is a severe psychiatric disorder leading to both cognitive and functional impairment with a substantial impact on social and working life. BD often has its onset in late adolescence and early adulthood, coinciding with the development of sexual identity. Healthy sexual development is important for gaining autonomy in one's sexual decision-making and healthy sexual relations, which contributes to enhancing the quality of life. Individuals with mental health disorders have a higher risk of sexual problems impacting intimate relations and quality of life. For individuals with BD the mood shifts might to a particular degree affect their sexual function with possible hypersexual interest during manic episodes and with low sexual interest during depressive episodes.
In the BIDISEX project we want to explore the impact of BD one peoples sexual life. The focus is on sexual problems related to mood changes and the effect on the relationship, quality of life, and how to cope with BD and intimacy. The project consists of two studies 1) A cross-sectional case-control study where 140 individuals with BD will be compared to a national representative group 2) A 6-month prospective follow-up study of the 140 individuals with BD, recruited in study 1, with three observation times. The outcomes are different sexual parameters measured with questionnaires, which is golden standard in sexological research.
The EDIT-B clinical validation study:
Differentiation between bipolar and unipolar disorder during depressive phases represents a major clinical issue. Misdiagnosis delay has profound consequences for patients resulting in inadequate treatment and substantial impairment in socio-occupational functioning. A recent clinical discovery study identified a panel of RNA-editing blood biomarkers (which constitutes the EDIT-B test system) of patients with depression that allowed a differential diagnosis of bipolar disorder from unipolar depression. The objective of the present study is to provide an external validation of the diagnostic performances of the EDIT-B® signature on bipolar versus unipolar differentiation in patients with depression.
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