The overall aim of BrainDrugs is to establish which key features predict drug response in patients with epilepsy or major depression disorder (MDD).
Depression is the leading cause of disability worldwide. Meanwhile, there is growing evidence that Major Depressive Disorder (MDD) describes not just one but several subtypes of brain disorders, each with potentially different biological and psychological causes and disease mechanisms. Possibly, why almost one in three patients do not respond to standard treatment with first- or second-line antidepressants.
Establishing the deep phenotyping depression cohort is part of the BrainDrugs thematic research alliance within precision medicine in epilepsy and depression funded by the Lundbeck Foundation. The project is in collaboration with the Mental Health services in the Capital Region, by Professor Martin Balslev Jørgensen and PhD-student Kristian Reveles Jensen.
We aim to identify clinically relevant predictors that can reliably identify subtypes and predict treatment response in MDD, thereby improving patient recovery. We examine patients before initiating a standard treatment package for first-episode MDD at six outpatient clinics in the Capital Region of Denmark in a prospective naturalistic cohort study.
We aim to enrol 800 patients in total and follow them up at three follow-up time points: at the end of the treatment package, and 12 and 18 months after treatment start with additional long-term follow-up in civil and health registers. We examine a combination of possible predictive markers across several domains, e.g., demographic, clinical, genetics, blood markers, and several neuroimaging modalities in subgroups, to predict treatment response and examine their role in disease mechanisms.
The study will consist of three cohorts:
Cohort I (n=200) will contribute with basic clinical, cognitive, psychometric, and biological data.
Cohort II (n=540) will contribute with expanded clinical, cognitive, psychometric, and biological data as well as Magnetic Resonance Imaging (MRI) and Electroencephalogram (EEG) data.
Cohort III (n=60) will be exclusively for patients unmedicated at initiation and consist of the same investigation as Cohort II with the addition of Positron Emission Tomography (PET) imaging with the [11C]-UCB-J tracer of synaptic density.