Variables | Sources | Study period | |||||
---|---|---|---|---|---|---|---|
Enrolment | Intervention | Follow-up | |||||
Screening | Baseline (week 0) | Visit 2 (week 2) | Visit 3 (week 10) | Visit 4 (week 20) | Visit 5 (week 24) | ||
MADRS | Rater | X | Â | X | X | X | X |
MES, WHO-5, GAF-S, GAF-F, CGI-S YMRS | Rater/self-reported | Â | X | X | X | X | X |
M.I.N.I.-Interview | Rater | X | Â | Â | Â | Â | Â |
Demographic (age, gender, height, inclusion site, etc.) | Self-reported | Â | X | Â | Â | Â | Â |
Weight and BMI | Rater | Â | X | X | X | X | X |
Personal and demographic details (income source, education, relationship etc.) | Self-reported | Â | X | Â | Â | Â | Â |
Family mental history | Self-reported | Â | X | Â | Â | Â | Â |
Lifestyle information (smoking status, alcohol consumption and substance abuse) | Self-reported | Â | X | X | X | X | X |
Disorder information (no. of: episodes of depression, hypomania/mania, neutral mood, ECT, hospital admissions, suicidal thoughts, suicide attempts, etc.) | Self-reported/hospital record | Â | X | Â | Â | Â | Â |
Medical conditions (Doctor diagnosed) | Self-reported | Â | X | Â | Â | Â | Â |
Pharmacological treatment | Hospital record | Â | X | X | X | X | X |
Psychological treatment | Self-reported | Â | X | X | X | X | X |
Adverse events/reactions | Self-reported | Â | X | X | X | X | X |
Biography | Self-reported | Â | Â | X | Â | Â | Â |
Urine samples | Laboratory | Â | X | X | X | X | X |
Blood samples | Laboratory | Â | X | Â | Â | X | X |
DNA | Laboratory | Â | X | Â | Â | X | X |