Table 2.
Work package | Aims |
---|---|
1 | Project administration |
2 | Set-up, ethical approval, database development |
3 |
Identification of baseline & follow-up assessment of clinical symptoms, neuropsychological and social functioning, illness activity, etc Characterisation of the clinical response phenotype for lithium treatment according to pre-defined outcome measures (categorical/continuous) Assessment & optimization of medication adherence Economic modelling of using a stratified approach to prescribing lithium; Qualitative & quantitative assessment of the digital phenotype Development of a prototype device for salivary lithium measurement |
4 | Examination of neuro-imaging (MRI and 1H-spectroscopy) signature before & after lithium initiation to allow repeated assessment of e.g. architecture of the amygdala, etc |
5 | Assessment of 7Li-MRI signature (i.e. distribution of lithium in the brain measured 12 weeks after initiation of treatment) |
6 | Blood sampling to measure omics (e.g. putative transcriptomic, mirnomic, methylomic and proteomic biomarkers) before & after lithium initiation to explore potential molecular signatures |
7 |
Data management infrastructure for e.g. data collection of heterogeneous data (imaging, genetics, clinical) across different institutions & countries; Quality control of data processing; controlled data sharing; etc Data analysis |
8 | Evaluation of laboratory to bedside transferability of study findings according to e.g. clinical feasibility, technical feasibility, utility of markers when employed alone or in combination (i.e. additivity or redundancy), acceptability & cost effectiveness |
9 | Communication & dissemination of findings |