|
Acute phase
|
---|
0
|
Week 2, day 14 (± 3)
|
Week 4, day 28 (± 3)
|
Telephone interview (week 6)
|
Week 8, day 56 (± 3)
|
Telephone interview, week 10 (for patients who change drugs in week 4)
|
Week 12 (± 7)/early termination
|
---|
Informed consent
|
×
| | | | | | |
Inclusion/exclusion criteria
|
×
| | | | | | |
General data
|
×
| | | | | | |
Medical history and mental symptoms
|
×
| | | | | | |
MINI
|
×
| | | | | | |
Somatic and neurological examination
|
×
| | | | | | |
Vital signs/weight
|
×
| |
×
| |
×
| | |
QIDS-SR 16
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
FIBSER
|
×
|
×
|
×
|
×
|
×
|
×
|
×
|
PDQ-9
|
×
| |
×
| |
×
| |
×
|
SDS
|
×
| |
×
| |
×
| |
×
|
FBS
|
×
| |
×
| |
×
| |
×
|
Q-LES-Q-SF
|
×
| |
×
| |
×
| |
×
|
HAMD-17
|
×
| |
×
| |
×
| |
×
|
YMRS
|
×
| |
×
| |
×
| |
×
|
Acceptability/feasibility
| |
×
|
×
| |
×
| |
×
|
Adverse reactions
|
×
|
×
|
×
|
×
|
×
| |
×
|
Biological sample collection
|
×
|
×
| | | | |
×
|
- MINI Mini-International Neuropsychiatric Interview, QIDS-SR 16 16-item Quick Inventory of Depressive Symptomatology–Self-Report, FIBSER Frequency, Intensity, and Burden of Side Effects Rating scale, PDQ-9 Patient Health Questionnaire-9, SDS Self-Rating Depression Scale, FBS Family Burden Scale of Disease, Q-LES-Q-SF Quality of Life Enjoyment and Satisfaction Questionnaire–Short Form, HAMD-17 17-Item Hamilton Rating Scale for Depression, YMRS Young Mania Rating Scale