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Table 1 Schedule of assessments

From: Pharmacist-guided pre-emptive pharmacogenetic testing in antidepressant therapy (PrePGx): study protocol for an open-label, randomized controlled trial

Day

Pre-study

Run-in phase

Treatment phase

Follow-up

Clinic discharge

−8

−7

−7–0

0

7

14

21

28

35, 42..

 

Informed consent for trial participation

x

         

Eligibility (pregnancy test, drug screening, inclusion, & exclusion criteria)

x

         

Buccal swab (Stratipharm®)

 

x

        

Medical history (previous antidepressant therapies)

  

x

       

Lab values (basic hematology, creatinine (eGFR), ASAT, ALAT, total bilirubin, gamma-GT, CRP, TSH, vit. B12, and vit. D)

  

x

      

x

Concomitant medication documentation

  

x

x

x

x

x

x

x

x

RANDOMIZATION (only if new antidepressant indicated)

   

x

      

PGx pharmaceutical recommendation (only arm A)

   

x

      

Start NEW antidepressant

   

x

      

HAM-D17

x

  

xa

xc

x

xc

x

x

x

AE assessment (antidepressant therapy only)

    

xc

x

xc

x

x

x

FIBSER patient self-assessment

   

xa

xc

x

xc

x

x

x

BDI-II patient self-assessment

   

xa

 

x

 

x

xb

x

Blood sample collection (EDTA and serum)

     

x

 

x

  
  1. aBaseline scoring before the first intake of new antidepressant
  2. bBDI-II assessed in two weekly intervals
  3. cOnly for study arms A and B