Baseline | Treatment phase | Follow-up phase | |||||
Week | Week | Week | Week | Month | Month | Month | |
–1 | 0 | 4 | 8 | 1 | 3 | 6 | |
Patients | |||||||
Enrollment | × | ||||||
Signed informed consent | × | ||||||
Medical history | × | ||||||
Merger disease | × | ||||||
Randomisation | × | ||||||
Intervention | × | × | |||||
Primary outcomes | |||||||
PSQI | × | × | × | × | × | × | |
Secondary outcomes | |||||||
Actigraphy | × | × | × | ||||
HAMD | × | × | × | × | × | × | |
SAS | × | × | × | ||||
TESS | × | × | × | × | × | ||
Drug dose record | × | × | × | × | × | × | |
Patients’ compliance | × | × | × | × | × |
HAMD, Hamilton Rating Scale for Depression; PSQI, Pittsburgh Sleep Quality Index; SAS, Self-rating Anxiety Scale; TESS, Treatment Emergent Symptom Scale.