Psychiatric Disorder Clinical Trial
Official title:
Prospective Randomised Double Blind Trial of Ketiapine and Olanzapine Comparative Efficacy for Fast Sedation of Severely Agitated Patients in Emergency Psychiatric Ward
comparison of intramuscular olanzapine and ketamine efficacy as first medication for fast sedation of patients with agitation and aggressive behavior. Five hundred patients with agitation caused by psychiatric disorder were randomly assigned under double-blind conditions to receive olanzapine or ketiapine. The Overt Agitation Severity Scale, Overt Aggression Scale and Ramsay Sedation Scale will be applied within 12 hours after the first dosage.
double-blind controlled trial to compare effectiveness of intramuscular olanzapine and
ketamine as first medication to fast sedation of patients with agitation caused by
psychiatric conditions. Randomization will be performed by permuted blocks allocation in
which ketiamine or olanzapine standard treatment will be assigned to blocks of five patients
and distributed in this order: olanzapine and ketiamine. This assignment will be repeated
until the total number of subjects (500) be reached.
agitation status will be operationalized using Overt Agitation Severity Scale Total Score
(OASS) equal or greater than 20 and Overt Aggressive Scale (OAS) with four or more positive
items. Full physical and neurological examination will be completed as soon as possible,
whenever patient is considered eligible for the study. Written Informed consent should be
provided before and after participating in this study, and should be reviewed and approved by
the institutional review board. Written consent obtained before admission to the emergency
ward by legal guardian and after 12 hours by the patient (whenever he or she is is able to
understand the information) or by the guardian. This study will comply with principles of the
Declaration of Helsinki and Good Clinical Practice and approved by the Institutional Review
Board (IRB) of Hospital Larcade of San Miguel County (Province of Buenos AIres (Project
msm001) inter-rater reproducibility will be evaluated by two raters which will repeatedly
apply OASS, OAS and RSS to patients admitted to the emergency room before the study until the
intraclass correlation coefficient (ICC) reach a score of 0.80 or greater medications will be
packaged in identical color-coded boxes and dosage of of olanzapine and ketiamine will be
determined according to standard protocols and previous studies.
If a subject needs another intervention will be removed from the study. subjects will be
assessed from 1 to 12 hours after administration of selected medication.
psychiatrists will be masked to patient's treatment assignment, and patients will be
instructed not to reveal current treatment to investigators.
clinical safety of treatment will be assessed by notification and with an close-ended inquiry
into adverse events together with full physical examination and vital signs measurements.
Statistical analyses mean and standard deviation (SD) and comparisons of baseline demographic
and clinical characteristics with one-way analysis of variance (ANOVA), chi-square test for
categorical variables and mixed-effect analyses of covariance (ANCOVAs) with medication
(olanzapine, ketiamine) as between-groups factor and time (1 hour, 2 hours, 4 hours, 6 hours
and 12 hours) as a within-group factor. OASS at time zero, OAS at time zero, and presence of
excessive sedation will be fixe covariates, and symptom ratings (OASS, OAS and RSS) will be
time-varying covariates.
differences between groups at each time point and variance with post-hoc Duncan's tests will
be calculated to compare mean OASS, OAS and RSS scores between groups.
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