| V1 | V2 | V3 | V4 | V5 | V6 | V7 | |
---|---|---|---|---|---|---|---|---|
 | Screening | Baseline | Treatment start | Week 2 | Week 6 | Week 10 (EOT) | End visit (EOS) week 16 | |
 | month − 2 ± 2 | day − 3 (±2) | day 1 | day 15 (±3) | day 43 (±3) | day 73 (±3) | day 113 (±7) | |
Randomization | Â | Â | X | Â | Â | Â | Â | Â |
Intake of study drug | Â | Â | X------> | ----------- | ------------ | --------X | Â | Â |
Information about study objectives and informed written consent | X | Â | Â | Â | Â | Â | Â | Â |
Inclusion and exclusion criteria | X | X | Â | Â | Â | Â | Â | Â |
Medical history | Â | X | Â | Â | Â | Â | Â | Â |
Sociodemographic data | Â | X | Â | Â | Â | Â | Â | Â |
Anthropometric data (height, weight, waist Circumference, hip circumference, BMI) | Â | X | Â | Â | Â | Â | X | Â |
Weight (BMI) | Â | X | X | X | X | Â | X | X |
12-channel ECG | Â | X | Â | Â | Â | Â | X | Â |
Urine pregnancy test | Â | X | Â | Â | Â | Â | X | Â |
Vital parameters (HR, RR) | Â | X | X | X | X | Â | X | Â |
Physical examination | Â | X | Â | X | Â | Â | X | Â |
Gynecological examination | Â | X | Â | Â | Â | Â | Â | Â |
Inclusion criteria and contraindications before first intake (gynecological findings, liver parameters, RR etc.) | Â | Â | X | Â | Â | Â | Â | Â |
EDE-Q | Â | Â | X | Â | Â | Â | X | X |
EDI-2 | Â | Â | X | Â | Â | Â | X | X |
STAI | Â | Â | X | Â | Â | Â | X | X |
PHQ-9 | Â | Â | X | Â | Â | Â | X | X |
EDQOL | Â | Â | X | Â | Â | Â | X | X |
Neuropsychological test battery: verbal intelligence test, TMT A and B, Go/NoGo-test with food stimuli, WCST | Â | Â | X | Â | Â | Â | X | Â |
Dexamethasone-suppression test/plasma cortisol concentration (5) | Â | Â | X | Â | Â | X | Â | Â |
Plasma sex hormones (4) | Â | X | Â | X | X | X | Â | Â |
OGTT for the assessment of plasma ghrelin, leptin, glucose and insulin (6) | Â | X | Â | Â | Â | X | Â | Â |
Routine laboratory tests (1)(2)(3) and urine dipstick | Â | X | Â | X | Â | X | Â | Â |
Assessment of concurrent medication | Â | X | X | X | X | X | X | X |
Assessment of adverse events | Â | Â | X | X | X | X | X | X |