Study stage |
D−7
(inclusion visit) |
D0
(randomisation visit) | D7 |
M1
(±7 days) |
M2
(±7 days) |
M3
(±15 days) |
M6
(±15 days) |
M9
(±15 days) |
M12
(±15 days) |
Visits (C: centre; T: telephone call) | C | C | C | C (group A) | T | C | T | C | |
Inclusion/exclusion criteria applied | X | ||||||||
Inclusion and randomisation | X | ||||||||
Disease history, medical history and associated treatments | X | ||||||||
Scored using MADRS, Clinical Global Impression–Severity and Montreal Cognitive Assessment | X | X | X | X | X | ||||
EuroQol Five-Dimension questionnaire | X | X | X | X | X | X | X | ||
Group A (tDCS-TAU): initial round of tDCS sessions (5 days/week for 3 weeks) | |||||||||
Group A: additional rounds of tDCS in event of relapse (if patient responds well); total number of rounds is patient-dependent | |||||||||
tDCS acceptability | X | ||||||||
Compliance (MARS and Brief Medication Questionnaire) | X | X | |||||||
Adverse events | X | X | X | X | X | X | X | ||
Summary of depression treatments (pharmacological or other treatments) | X | X | X | X | X | X | X | ||
Health economic data | X* | X† |
*Microcosting with electronic case report form.
†Medical resource consumption per NHSD.
Dn , day; MADRS, Montgomery-Åsberg Depression Rating Scale; MARS, Medication Adherence Rating Scale; M n , month; NHSD, National Health System Database; TAU, treatment as usual; tDCS, transcranial direct current stimulation.