| Visit 1 − 12 to 0 weeks (screening) | Visit 2 week 0 (baseline) | Visit 3 week 1 | Visit 4 week 2 | Visit 5 week 3 | Visit 6 week 4 | Visit 7 week 5 | Visit 8 week 6 (end of treatment) | Visit 9 week 16 | Visit 10 week 26 | Visit 11 week 52 | Early termination visit* |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Informed consent, MINI, demographics | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Eligibility criteria | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Medical history, current medical conditions | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Physical examination, BMI, ECG | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Pregnancy testing | X | X | Â | Â | Â | Â | Â | X | Â | Â | Â | X |
MRI** | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | X | Â |
Use of concomitant medication | X | X | X | X | X | X | X | X | X | X | X | X |
Dispense study medication | Â | X | X | X | X | X | X | Â | Â | Â | Â | Â |
Randomization | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Drugs/alcohol use | X | Â | Â | Â | X | Â | Â | X | Â | Â | Â | X |
Side effects, compliance | Â | Â | X | X | X | X | X | X | Â | Â | Â | X |
PANSS, GAF | X | X | Â | X | Â | X | Â | X | X | X | X | X |
Suicidal behavior, CDS, hospitalization | Â | X | X | X | X | X | X | X | X | Â | Â | X |
BACS | Â | X | Â | Â | Â | Â | Â | X | Â | X | Â | X |
Blood/ urine samples | X | X | *** | *** | X | *** | *** | X | Â | X | Â | X |