|
Assessments
|
V0
|
V1
|
V2
|
V3
|
V4
|
V5
|
V6
|
V7
|
V8
|
V9
|
V10
|
V11
|
|---|
|
Scr
|
WK1
|
WK3
|
WK4
|
WK5
|
WK6
|
WK7
|
WK8
|
WK9
|
WK10
|
WK11
|
WK12
|
|---|
|
Informed consent
|
X
| | | | | | | | | | | |
|
Med history & physical exam
|
X
| | | | | | | | | | | |
|
CAPS-5
|
X
| | | | | | | | | | |
X
|
|
PCL-5
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
PSQI
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
PHQ-9
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
QOLS
|
X
| | | | | | | | | | |
X
|
|
WHODAS 2.0
|
X
| | | | | | | | | | |
X
|
|
PTGI
|
X
| | | | | | | | | | |
X
|
|
Medication diary
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
Medication dosing
| |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
Medication adjustment
| |
X
|
X
| |
X
| | | |
X
| | |
X
|
|
Adverse effects
| | |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
Psychotherapy
| | |
S1
|
S2
|
S3
|
S4
|
S5
|
S6
|
S7
|
S8
|
S9
|
S10
|
|
Self-report of engagement
| | |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
Vital signs
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
Labs
|
X
| | | | | | | | | | |
X
|
|
ECG
|
X
| | | | | | | | | | |
X
|
- Shown are procedures completed at visits (V#) / weeks (WK) of study. Screening (Scr) occurs at V0 and medication reduction or initiation occurs from Weeks 1–3
- Abbreviations: CAPS-5 Clinician-Administered PTSD Scale for DSM-5, PCL-5 PTSD Checklist for DSM-5, PSQI Pittsburgh Sleep Quality Index, WHODAS 2.0 World Health Organization Disability Assessment Schedule 2.0, QOLS Quality of Life Scale, PHQ-9 Patient Health Questionnaire, PTGI Post Traumatic Growth Inventory, ECG 12-lead electrocardiogram
