Table 2.
Outline of trial visits
| Assessments | SC | BL Visit 1 W 0 |
Visit 2 W 1 |
Visit 3 W 2 |
Visit 4 W 3 |
Visit 5 W 4 |
Visit 6 W 6 |
Visit 7 W 8 |
Visit 8 W 10 |
FU Visit 9 W 12 |
|---|---|---|---|---|---|---|---|---|---|---|
| Screening and consent | ||||||||||
| Inclusion/exclusion criteria | X | |||||||||
| Informed consent | X | |||||||||
| Physical examination1 | X | X | ||||||||
| Prior and concomitant medi-cation and non-drug therapy | X | X | X | X | X | X | X | X | X | X |
| Medical history | X | |||||||||
| IMP dispersion | X | X | X | X | X | X | X | |||
| IMP return | X | X | X | X | X | X | X | |||
| Safety | ||||||||||
| Blood test2 | X | X | ||||||||
| Cannabis test | X | |||||||||
| Pregnancy test | X | X | X | X | X | X | X | |||
| ECG | X | X | (X)3 | |||||||
| Blood pressure, pulse | X | X | X | X | X | X | X | X | X | X |
| Weight | X | X | X | X | X | |||||
| Adverse event recording | X | X | X | X | X | X | X | X | X | |
| Effectiveness | ||||||||||
| Primary | ||||||||||
| CAPS-IV B2 | X | |||||||||
| Secondary | ||||||||||
| CAPS-IV B2 | X | X | X | X | X | X | X | X | ||
| CAPS-5 | Xa | Xb | Xb | Xb | ||||||
| PSQI-A | X | X | X | |||||||
| MADRS | X | X | X | X | ||||||
| Sleep diary | X | X | X | X | X | X | X | X | ||
| PCL-5 | X | X | X | |||||||
| BSL-23 | X | X | X | |||||||
| EQ-5D | X | X | X | |||||||
| PGIC | X | X | ||||||||
| SOFAS | X | X | X | |||||||
| PSQI | X | X | X | |||||||
| ITQ | X | X | X | |||||||
| MWC | X | X | X | X | ||||||
| Others | ||||||||||
| Demographics | X | |||||||||
| CTQ | X | |||||||||
| MINI-5 | X | |||||||||
| ITI | X | |||||||||
SC Screening, W. week ± 3 days, BL Baseline and randomization, FU Post-trial follow-up, CAPS-IV B2 B2 score of the Clinician-Administered PTSD Scale for DSM-IV (frequency and intensity of nightmares), CAPS-5 Clinician-Administered PTSD Scale for DSM-5 (a = last month version, b = last week version), PSQI-A Pittsburgh Sleep Quality Index-Addendum for PTSD, MADRS Montgomery–Åsberg Depression Rating Scale, PCL-5 PTSD Checklist for DSM-5, BSL-23 Borderline Symptom List 23, EQ-5D Health-Related Quality of Life, PGIC Patient Global Impression of Change, SOFAS Social and Occupational Functioning Assessment Scale, PSQI Pittsburgh Sleep Quality Index, ITQ International trauma questionnaire, MWC Marijuana Withdrawal Checklist, CTQ Childhood trauma questionnaire, MINI-5 The Mini International Neuropsychiatric Interview for DSM-5, ITI International Trauma Interview
1Physical examination includes height and weight of the patient and the skin, abdomen, respiratory system, head and extremities will be examined
2blood test s include haematology (erythrocytes, haemoglobin, haematocrit, platelets, leukocytes (including neutrophils, eosinophils, basophils, lymphocytes, monocytes) and serum chemistry (sodium, potassium, chloride, calcium, creatinine, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, aspartate aminotransferase, bilirubin, lipase, thyroid stimulating hormone)
3In case of significant abnormal ECG findings at the visit 8 (week 10), a further ECG will be recorded at the follow-up visit