Table 1.
A synopsis of study procedures from visit 1 (V1) to visit 7 (V7)
| 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 | X | |||||||
| Intake of study drug | X------> | ----------- | ------------ | --------X | ||||
| Information about study objectives and informed written consent | X | |||||||
| Inclusion and exclusion criteria | X | X | ||||||
| Medical history | X | |||||||
| Sociodemographic data | X | |||||||
| Anthropometric data (height, weight, waist Circumference, hip circumference, BMI) | X | X | ||||||
| Weight (BMI) | X | X | X | X | X | X | ||
| 12-channel ECG | X | X | ||||||
| Urine pregnancy test | X | X | ||||||
| Vital parameters (HR, RR) | X | X | X | X | X | |||
| Physical examination | X | X | X | |||||
| Gynecological examination | X | |||||||
| Inclusion criteria and contraindications before first intake (gynecological findings, liver parameters, RR etc.) | X | |||||||
| EDE-Q | X | X | X | |||||
| EDI-2 | X | X | X | |||||
| STAI | X | X | X | |||||
| PHQ-9 | X | X | X | |||||
| EDQOL | X | X | X | |||||
| Neuropsychological test battery: verbal intelligence test, TMT A and B, Go/NoGo-test with food stimuli, WCST | X | X | ||||||
| Dexamethasone-suppression test/plasma cortisol concentration (5) | X | X | ||||||
| Plasma sex hormones (4) | X | X | X | X | ||||
| OGTT for the assessment of plasma ghrelin, leptin, glucose and insulin (6) | X | X | ||||||
| Routine laboratory tests (1)(2)(3) and urine dipstick | X | X | X | |||||
| Assessment of concurrent medication | X | X | X | X | X | X | X | |
| Assessment of adverse events | X | X | X | X | X | X | ||
1 hematology: hemoglobin (Hb), hematocrit, red blood cells, white blood cells, platelets, differential blood count, coagulation parameters (Quick/ PTT)
2 clinical chemistry: sodium, potassium, urea, chloride, creatinine, bilirubin, GOT, GPT, gamma-GT, alcaline phosphatase, lipase, LDH, CRP
3 fasting lipids
4 sex hormones: LH, FSH, estradiol, testosterone
5 dexamethasone-suppression test: 1 mg dexamethasone per os at 11.00 PM followed by fasting blood collection at 08.00 AM for plasma cortisol
6 OGTT (oral glucose tolerance test): blood draw before intake of glucose suspension (0 min) as well as 30, 60, 90 und 120 min after ingestion
TMT A and B Trail Making Test A and B, WCST Wisconsin Card Sorting Test