Rationale and design of the PLACID study: a randomised trial comparing the efficacy and safety of inhaled loxapine versus IM aripiprazole in acutely agitated patients with schizophrenia or bipolar disorder

San, L.; Estrada, G.; Oudovenko, N.; Vieta, E.

doi:10.1186/s12888-017-1291-5

Table 1 PLACID study flow

From: Rationale and design of the PLACID study: a randomised trial comparing the efficacy and safety of inhaled loxapine versus IM aripiprazole in acutely agitated patients with schizophrenia or bipolar disorder

Procedure	Pre-treatment period		Post-treatment evaluation period
	Screening^a (up to 4 h)	Baseline (within 30 min prior to dose 1)	Time 0					1 h		2 h	4 h	24 h or end of the agitation episode, whichever occurs first
	Screening^a (up to 4 h)	Baseline (within 30 min prior to dose 1)	0 min	10 min	20 min	30 min	50 min	60 min	90 min	120 min	240 min
Informed consent^b	X
Inclusion/exclusion criteria	X	X^c
Demographics	X
Medical history	X
Pre-dose medications	X^d	X^d
Physical examination^e	X											X
Urine pregnancy test (females of child-bearing potential)^f	X
Randomisation		X
Study drug administration			X	← NOT ALLOWED →							Up to 1 dose PRN^g
CGI-S Scale^h		X
CGI-I Scale^h				X ± 2 min	X ± 2 min	X ± 2 min	X ± 2 min	X ± 5 min	X ± 5 min	X ± 5 min		X ± 1 h
TSQM (Item 14)^h										X		X
Vital signs^h,i		X						X		X	X	X
AEs^j			X→	→	→	→	→	→	→	→	→	X
Concomitant medications^k	X→	→	→	→	→	→	→	→	→	→	→^k	X^k
Discharge from the study												X

AE adverse event, CGI-I Clinical Global Impression of Improvement, CGI-S Clinical Global Impression of Severity, eCRF electronic case report form, HCG human chorionic gonadotropin, ICF informed consent form, PRN pro re nata (as needed), TSQM Treatment Satisfaction Questionnaire for Medication. ^aPatients must remain in the study centre during screening. ^bThe approved ICF must be signed by patients with consent capacity before completing any protocol-specific procedures. ^cInclusion criteria #3 and 4 and Exclusion criteria 4 and 12 will be assessed at baseline. ^dAll medications taken within 30 days of the study start, includind medications taken in the 24 hours prior to the first dose of study medication, should be recorded on the eCRF. ^eBaseline and end-of-study examinations will be completed; other examination should be a focused physical examination at the discretion of the Investigator based on the patient's circumstances. ^fFemales of documented postmenopausal status and inpatients who previously tested negative for pregnancy (serum β-HCG) upon admission are not required to undergo the urine test at screening. ^gNote that patients who only receive one dose of study drug (Dose 1) may not be given rescue medication (unless medically required). Rescue medication may be administered per the Investigator's judgement from 20 minutes after Dose 2 of the study medication has been given (and after the 2-hour efficacy assessments have been completed). ^hAt all time points, perform rating scales/ assessments in the following order, as applicable: CGI, TSQM (Item 14), vital signs. ⁱPulse, systolic and diastolic blood pressure and respiraion rate will be recorded. ^jAEs will be recorded for at least 24 hours after Dose 1 or the study medication or the end of the agitation episode as per the Investigator's judgement, whichever occurs first. Patients should be monitored for bronchospasm for => 1 hour after Dose 1 and Dose 2 (if Dose 2 is administered). ^kConcomintant medications, including those to treat AEs, will include all medications that patients were already taking at the time of screening or started during the course of the study. If rescue medication is taken, the time that it is taken will be recorded. Whether rescue medication has been taken by 4 hours and by 24 hours after Dose 1 or the end of the agitation episode as per the Investigator's judgement, whichever occurs first, will be recorded

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