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CompletedPhase 4

Randomised Trial Ketiapine Olanzapine Fast Sedation Agitated Patients Emergency Ward

NCT03216941 · IM-OK-FAST · Universidad Nacional de Rosario

Closed to entry
Status
Not accepting participants
Phase 4
Phase
500
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • sedation status

    Measured over 1 to 12 hours

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * signs of agitation, * age between 18 and 64 years, * bipolar (maniac or mixed episode) * psychotic disorder diagnosis * disorders due to drug abuse, * organic disorder, * anxiety or personality disorder * Overt Agitation Severity Scale Total Score (OASS) equal or greater than 20 * Overt Aggressive Scale (OAS) with four or more positive items. Exclusion Criteria: * failure to agree to participate in the study, * incapability of completing all steps * unstable clinical disease - * pregnancy

Where

1 study site

FacilityCityRegionCountry
hospital LarcadeSan MiguelBuenos AiresArgentina

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03216941 on ClinicalTrials.gov →

Last updated in the registry 2017-07-13. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance