The establishment of the objective diagnostic markers and personalized medical intervention in patients with major depressive disorder: rationale and protocol

Table 2 Data Collection at Screening, Baseline and Follow-up Evaluation

Domain	Measure	Participant	Method	Assessment time	Administrator
Informed consent	Informed consent	All participants	Interview	Screening	Investigator
Eligibility	Inclusion/Exclusion	All participants	Interview	Screening	Investigator
Psychiatric diagnoses	MINI	All participants	Interview	Screening	Investigator
Demographic, medical history, family history of psychiatric disease and MDD course	Self-designed questionnaire	All participants^a	Self-report	Baseline	Investigator
Life events in the past year, adverse childhood experience, social support, coping style, personality trait	LES, CTQ, SSQ, SCSQ,EPQ	All participants	Interview	Baseline	Investigator
Treatment process, concurrent treatment, stress events, mood disorder episodes and adverse events	Self-designed questionnaire	600-MDD patients subgroup	Self-report	Every follow-up	Investigator
Anxiety symptom	HAMA	600-MDD patients subgroup	Interview	Every follow-up	Investigator
Depressive symptom severity	HRSD₁₇	600-MDD patients subgroup	Interview	Baseline and every follow-up	Investigator
Depressive symptom improvement	CGIS	600-MDD patients subgroup	Interview	Every follow-up	Investigator
Cognitive function	CPT-IP, AVFSS, CTTI and II, BACS, BVNT-R, HVLT-R, SCWT	600-MDD patients and 300-Health controls subgroup	Interview	Baseline, week 8 and 48^b	Investigator and computerized touch screen platform^c

Abbreviations: MINI Mini-International Neuropsychiatric Interview, LES Life Events Scale, CTQ Childhood Trauma Questionnaire, SSQ Social Support Questionnaire, SCSQ Simplified Coping Style Questionnaire, EPQ Eysenck Personality Questionnaire, HAMA Hamilton Anxiety Scale, HRSD₁₇ 17-Item Hamilton Rating Scale for Depression, CGIS Clinical Global impression Scale, CPT-IP Continuous Performance Test-Identical Pairs, AVFSS Animal Verbal Fluency Scale, CTTIand II = Color Trial Test I and II, BACS the Brief Assessment of Cognition in Schizophrenia, BVNT-R Brief Visual Memory Test-Revised, HVLT-R Hopkins Verbal Learning Test-Revised, SCWT Stroop Color Word Test
^a Except “MDD course” for 1200 MDD patients only, other data of this domain would be collected for all participants
^b For 300-Healthy controls subgroup, cognitive function data would only be collected at baseline
^c Except for the data of CPT-IP collected using a standardized computerized touch screen platform, other data of this domain would be collected by the trained investigator

ISSN: 1471-244X