Effects of erythropoietin on depressive symptoms and neurocognitive deficits in depression and bipolar disorder

Table 1 Overview of investigations

	Interventions/Assessment domains	Tests/Evaluations	Screening	Baseline & treatment start	Active treatment phase	Treatment-free follow-up period
				Week 1	(Week 2-8)	(Week 9-14)
Treatment	Investigational drug	EPO (40,000 IU)/Placebo	-	1×	7× (weekly)	-
Efficacy	Neurocognitive functions	Neuropsychological testing (120 min)	-	1×	-	2× (week 9,14)
		MRI, fMRI and cognitive tests	1×	-	-	1× (week 14)
	Psychopathology	Clinical Rating	-	1×	1× (week 5)	2× (week 9,14)
		Questionnaires	-	1×	1× (week 5)	2× (week 9,14)
	Quality of life questionnaires		-	1×	1× (week 5)	2× (week 9,14)
	DXA scan		-	1×	-	1× (week 9)
Safety	Physical exam		1×	1×	7× (weekly)	3× (week 9,10,14)
	Vital signs		1×	1×	7× (weekly)	3× (week 9,10,14)
	Urine pregnancy test		1×	1×	3× (week 3,5,7)	-
	ECG		1×	-	2× (week 3,5)	-
	Adverse event monitoring		-	Continuously until week 10
	Blood analysis	Haematology	1×	1×	7× (weekly)	3× (week 9,10,14)
		Blood chemistry	1×	1×	7× (weekly)	3× (week 9,10,14)
		BDNF, inflammatory and metabolic markers	-	1×	1× (week 5)	2× (week 9,14)

ISSN: 1745-6215