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Table 1 Schedule of activities

From: The translocator protein 18kDa ligand etifoxine in the treatment of depressive disorders—a double-blind, randomized, placebo-controlled proof-of-concept study

Study day

D − 1

D0

D1

D2

D3

D4

D5

T6

D7

D8

D14

D15

D22

D29

 

Screening

Baseline

Treatment phase

Follow-up

Screening/safety blood

X

          

X

 

X

Drug screening urine

X

             

Pregnancy test

XA

             

Medical history

X

             

MINI

X

             

Physical/neurological examination

X

            

X

Vital parameters

X

          

X

 

X

Body weight

X

          

X

 

X

Concomitant medication/(concomitant diseases)

X

          

X

  

HAMD-21, PHQ-9, VAS, MADRS

 

X

X

X

X

X

X

X

X

X

 

X

X

X

HAM-A, C-SSRS, BDI, SSS, BHWSS, BENDEP-SRW

 

X

       

X

 

X

X

X

Study medication

  

XB

XC

Assessment of adverse events

  

X

      

X

 

X

X

X

Study blood

 

X

         

X

 

X

CANTAB, ARENAD

 

X

         

X

  

fMRI

 

X

         

X

 

X

Cortisol Awakening Response

 

X

         

X

  

Microbiome

 

X

         

X

 

X

  1. AFor WOCBP
  2. B200 mg/day etifoxine or placebo
  3. CTreatment according to clinical judgment
  4. DThese two experimental paradigms can also be performed on D-1 after checking all inclusion/exclusion criteria