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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 instruments

Assessment target

Time pointsa

Baseline

Intervention period

Follow-up

< T0

T1

T2

T4

T6

T7

T8

T10

Primary and secondary outcomes

 HDRS17

Depressive symptoms (clinician-rated)

x

 

x

x

x

x

x

x

 IDS-SR

Depressive symptoms (patient-rated)

x

 

x

x

x

x

x

x

 CGI

Overall depression severity and change

x

 

x

x

x

x

x

x

 SHAPS

Hedonic capacity

x

   

x

  

x

 BSS

Suicidal ideation

x

   

x

  

x

 AMT

Autobiographical memory

x

   

x

  

x

 EQ-5D-5 L

Health related quality of life

x

   

x

  

x

 QPE

Psychotic experiences

x

x

  

x

  

x

 DSS

Dissociative features

x

x

  

x

  

x

 ISDI

Sleep disturbance

x

x

  

x

  

x

 SAFTEE

Side effects in any organ system

x

x

x

x

x

x

x

x

 Physical examination

Heart rate, blood pressure, weight

x

x

x

x

x

x

x

x

 Blood collection (I)

Liver enzyme levels

x

   

x

   

 Demographics questionnaire

Demographics

x

       

 DM-TRD

Treatment-resistance

x

       

 NEO-FFI

Neuroticism

x

       

 CEQ

Credibility and expectancy of intervention

x

       

Additional outcomes

 BAI

Anxiety symptoms

x

   

x

  

x

 GCPS

Pain

x

   

x

  

x

 FTND

Nicotine dependence

x

   

x

  

x

 Blood collection (II)

Biomarkers, gene expression, pharmacokinetics, CYP enzymes

x

x

  

x

  

x

 Urine collection

Biomarkers

x

   

x

  

x

 ZGV

Health care consumption

x

   

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