The benefit of minocycline on negative symptoms in early-phase psychosis in addition to standard care - extent and mechanism (BeneMin): study protocol for a randomised controlled trial

Table 3 Purpose and schedule of assessments in BeneMin

	Screening	Randomisation (Pre-treatment)	Month 2	Month 6	Month 9	Month 12 (Post-treatment)	Month 15 (Post-trial)
Inclusion and exclusion criteria checklist	EM
Case-note diagnostic checklist	EM
Diagnostic and eligibility checklist	EM and CO					CO
Mini-International Neuropsychiatric Interview	EM and CO					CO
Positive and Negative Syndrome Scale	EM and CO	CO	CO	CO	CO	CO	CO
Wechsler Adult Intelligence Scale III; 4 subtest short form	EM and CO					CO	CO
Wechsler Test of Adult Reading	EM and CO
Verbal fluency	EM and CO					CO	CO
Auditory-Verbal Learning Task	EM and CO					CO	CO
Medication treatment history	EM and CO	CO	CO	CO	CO	CO	CO
Pregnancy urine dipstick test	EM	WCM	WCM	WCM	WCM	WCM
Drug urine screening test	EM			WCM
Drug use questionnaire	EM	WCM	WCM	WCM	WCM	WCM	SCo
Blood laboratory screening for kidney and liver function	EM					WCM
Blood pressure and heart rate	EM					WCM	SCo
MRI screening questionnaire	EM
Duration of untreated psychosis	RP
Body weight and body mass index		CO				CO	CO
Global Assessment of Functioning		CO	CO	CO	CO	CO	CO
Social Functioning Scale		CO		CO		CO	CO
MRI scanning		BO				BO
Blood cytokine screen test		BO		BO		BO	BO
Saliva Oragene kit for DNA donation		RP
Withdrawal criteria checklist		WCM	WCM	WCM	WCM	WCM
Calgary Depression Scale for Schizophrenia		SCo	SCo	SCo	SCo	SCo	SCo
Simpson and Angus Scale		SCo		SCo		SCo	SCo
Barnes Akathisia Scale		SCo		SCo		SCo	SCo
Abnormal Involuntary Movements Scale		SCo		SCo		SCo	SCo
Antipsychotic Non-Neurological Side-Effects Rating Scale		SCo	SCo	SCo	SCo	SCo	SCo
7-point compliance scale			AT	AT	AT	AT

EM, eligibility measure; CO, clinical outcome; RP, response predictor; BO, biomarker outcome; WCM, withdrawal criteria measure; SCo, side-effects and co-morbidity; AT, adherence to treatment.
Intersections between lines and columns show if the test took place during the visit (cells containing an abbreviation). Abbreviations explicate the reason why the test was performed at a particular stage of the trial and how the particular measure fits into statistical design of the study.

ISSN: 1745-6215