Sequenced treatment alternatives to relieve adolescent depression (STAR-AD): a multicentre open-label randomized controlled trial protocol

Table 4 Schedule of events

item	Screening	Treatment						Follow-up
item	Screening	Level 1				Level 2		Follow-up
Instruments	V0	V1	V2	V3	V4^a	V5	V6^a	V7	V8	V9	V10
Informed consent	√
Clinical diagnosis	√
Physical examination	√			√	√	√	√
Demographic information		√
Record drug combination		√
Electrocardiogram examination (ECG)	√
MRI scan (if necessary)	√
Laboratory examination^b	√				√		√
Measures and assessment
CDRS-R^c	√	√	√	√	√	√	√	√	√	√	√
BDI^d		√		√	√	√	√	√	√	√	√
SCARED^e		√		√	√	√	√	√	√	√	√
C-SSRS^f	√	√		√	√	√	√	√	√	√	√
PSQI^g		√			√		√	√	√	√	√
PedsQL^h		√			√		√	√	√	√	√
HCL-32ⁱ		√		√	√	√	√	√	√	√	√
RSS^j		√			√
CGI-S^k		√		√	√	√	√
CGI-I^k				√	√	√	√
CTQ^l		√
OB/VQ^m		√
MMAS-8ⁿ				√	√	√	√	√	√	√	√
AEs			√	√	√	√	√	√	√	√	√
SAEs			√	√	√	√	√	√	√	√	√

^a V4 and V6 refer to the end of phase 1 and 2, respectively; phase 1 and 2 responders are followed for 12 months at the end of the 16-month treatment period; those who do not respond in phase 1 are followed for the next phase with a new treatment, monthly follow-up. Regardless of response at the end of phase 2, they will be followed for 12 months at the natural follow-up
^b Laboratory tests include routine blood, urine and stool tests, liver and kidney function tests, and thyroid function tests
^c CDRS = Children’s Depression Rating Scale
^d BDI = Beck Depression Inventory
^e SCARED = Screen for Child Anxiety-Related Emotional Disorders
^f C-SSRS = Columbia Suicide Severity Rating Scale
^g PSQI = Pittsburgh Sleep Quality Index
^h PedsQL4.0 = Pediatric Quality of Life Inventory 4.0 generic core scales
ⁱ HCL-32 = Hypomania Symptom Checklist-32
^j RSS = Ruminative Responses Scale
^k CGI-S = Clinical Global Impressions-Severity;CGI-I = Clinical Global Impressions-Improvement
^l CTQ = Childhood Trauma Questionnaire-Short Form
^m OB/VQ = Olweus Bully/Victim Questionnaire
ⁿ MMAS-8 = Morisky Medication Adherence Questionnaire

ISSN: 1471-244X