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Table 2 Schedule of assessments

From: Oral esketamine for treatment-resistant depression: rationale and design of a randomized controlled trial

Measurement instrumentsAssessment targetTime pointsa
BaselineIntervention periodFollow-up
< T0T1T2T4T6T7T8T10
Primary and secondary outcomes
 HDRS17Depressive symptoms (clinician-rated)x xxxxxx
 IDS-SRDepressive symptoms (patient-rated)x xxxxxx
 CGIOverall depression severity and changex xxxxxx
 SHAPSHedonic capacityx   x  x
 BSSSuicidal ideationx   x  x
 AMTAutobiographical memoryx   x  x
 EQ-5D-5 LHealth related quality of lifex   x  x
 QPEPsychotic experiencesxx  x  x
 DSSDissociative featuresxx  x  x
 ISDISleep disturbancexx  x  x
 SAFTEESide effects in any organ systemxxxxxxxx
 Physical examinationHeart rate, blood pressure, weightxxxxxxxx
 Blood collection (I)Liver enzyme levelsx   x   
 Demographics questionnaireDemographicsx       
 DM-TRDTreatment-resistancex       
 NEO-FFINeuroticismx       
 CEQCredibility and expectancy of interventionx       
Additional outcomes
 BAIAnxiety symptomsx   x  x
 GCPSPainx   x  x
 FTNDNicotine dependencex   x  x
 Blood collection (II)Biomarkers, gene expression, pharmacokinetics, CYP enzymesxx  x  x
 Urine collectionBiomarkersx   x  x
 ZGVHealth care consumptionx   x  x
  1. aNumber illustrates number of weeks after baseline. AMT Autobiographical Memory Test, BAI Beck Anxiety Inventory, BSS Beck Scale for Suicide Ideation, CEQ Credibility/expectancy questionnaire, CGI Clinical Global Impression, CYP Cytochrome P450, DM-TRD Dutch Measure for quantification of Treatment Resistance in Depression, DSS Dissociation Tension Scale, EQ-5D-5 L EuroQol 5D, FTND Fagerström Test for Nicotine Dependence, GCPS Graded Chronic Pain Scale, HDRS17 Hamilton Depression Rating Scale, IDS-SR Inventory of Depressive Symptomatology, ISDI Iowa Sleep Disturbance Inventory, NEO-FFI NEO Five-Factor Inventory, QPE Questionnaire for Psychotic Experiences, SAFTEE Systematic Assessment for Treatment Emergent Events, SHAPS Snaith Hamilton Anhedonia and Pleasure Scale, ZGV Health care use questionnaire (Zorggebruik Vragenlijst) – adapted from the TicP [63] to the context of the current study