The study protocol of the Norwegian randomized controlled trial of electroconvulsive therapy in treatment resistant depression in bipolar disorder

Table 4 Variable overview

	Study visit	1	2	3	4	5	6	7	8	9	10	Comment
	Week	-5t_1/2	0	1	2	3	4	5	6	26	30-52 ¹⁾	¹⁾ in euthymic phase
	Test
	Informed consent	X
Diagnostic interview	SCID or MINI plus	X
	Inclusion/exclusion criteria	X
NORBRAIN Entry Questionnaire NEQ	Socio demography Medical history etc	X
	PANSS	X
	GAF	X							X	X	X
	Clinical examination	X
	Current and concomitant medication	X	X	X	X	X	X	X	X	X	X
Health related Quality of Life	SF 36	X							X	X	X
Efficacy	MADRS	X	X²⁾	X	X	X	X	X	X²⁾	X	X	²⁾ audio taped
	IDS	X	X²⁾	X	X	X	X	X	X²⁾	X	X	²⁾ audio taped
	CGI-BP	X	X	X	X	X	X	X	X	X	X
	PGI-I			X	X	X	X	X	X	X	X
	YMRS	X	X	X	X	X	X	X	X	X	X
	MSIF	X								X	X
Relapse	Interview									X	X
Overall cognitive function	MMS ³⁾		X	X	X	X	X	X	X			³⁾ in ECT-group only
Neuropsychological assessment		X							X	X	X
	EMQ	X							X	X	X
Adverse events	Interview UKU		X⁴⁾			X			X			⁴⁾ previous med.
	SAE-form			X	X	X	X	X	X
Lab	Cytokines	X							X	X	X
	Cortisol ⁵⁾								X			⁵⁾ morning cortisol in blood
	Other, incl cortisol⁶⁾	X										⁶⁾ as specified in Blood samples
	ECG ⁷⁾	X										⁷⁾ if indicated
	EEG	X
	MRI caput	X
Substance abuse	Urin	X
Pregnancy	Urin ⁸⁾	X										⁸⁾ fertile woman
Compliance	Interview			X	X	X	X	X	X	X	X
Compliance	Blood sample					X
Temperament	TEMPS-A									X
Migrene	Interview	X								X

ISSN: 1471-244X