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Table 3 Doses escalation during the study follow up

From: What is the effectiveness and safety of mirtazapine versus escitalopram in alleviating cancer-associated poly-symptomatology (the MIR-P study)? A mixed-method randomized controlled trial protocol

 

Starting doses – Day 0

Day 7

Day 14

Day 28

 

Mirtazapine: 15 mg

Escitalopram: 10 mg (or 5 mg for patients older than 65)

   

Excessive drowsiness

(CTCAE grade 1 or rated moderate or severe using the ASEC)

 

For patients under 65 in the escitalopram arm: decrease to 5 mg

  

For every other patients: Stop the treatment

Any severe adverse effect or serious adverse event

(CTCAE grade > 3 or rated severe using the l’ASEC)

 

Stop the treatment

Moderate adverse event

(CTCAE grade 2 or rated moderate using the ASEC)

 

Decrease the dosage

(Or treatment stop if already at the lower dosage)

Mild adverse event

(CTCAE grade 1 or rated mild using the ASEC)

 

No dose adjustment

No adverse event

Inadequate symptoms’ control (ESAS > 3)

 

No dose adjustment

(or increase the dosage if escitalopram has been started at 5 mg)

Increase the dosage

Adequate symptoms’ control

(ESAS ≤ 3)

 

No dose adjustment