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NCT03211897 · ClinicalTrials.gov registry record

Olanzapine, Haloperidol, Ziprasidone, Midazolam for Acute Undifferentiated Agitation

A clinical trial of Agitation,Psychomotor, sponsored by Hennepin Healthcare Research Institute.

Completed
Registry status
737
Enrollment target
1
Study location

NCT03211897: Completed study of Agitation,Psychomotor, sponsored by Hennepin Healthcare Research Institute.

NCT03211897 is a study of Agitation,Psychomotor that has completed, run by Hennepin Healthcare Research Institute. The registered enrollment target is 737 participants, above the 212-participant average among 5 other Agitation,Psychomotor trials with a reported enrollment target (248% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03211897, a study of Agitation,Psychomotor, has completed, sponsored by Hennepin Healthcare Research Institute.

COMPLETED
Registry status
737 participants
Enrollment target
1
Study location

Study Summary

The goal of this research investigation is to conduct a prospective observational study of the comparative efficacy of haloperidol versus olanzapine versus midazolam versus ziprasidone for the treatment of acute undifferentiated agitation in the emergency department.

Primary Outcome

Patients score on a previously validated agitation scale called the AMSS ADDENDUM: The primary outcome for this study was changed prior to study initiation to the proportion of patients adequately sedated at 15 minutes (defined as AMSS \< 1). This addendum was methodologically necessary to account for the ordinal, non-normal distribution of this data.

Conditions Studied

Interventions

  • DRUG Haloperidol Injection
  • DRUG Ziprasidone Injection
  • DRUG OLANZapine Injection
  • DRUG Midazolam injection

Study Locations (1)

Minnesota

  • Hennepin County Medical Center - Minneapolis

Trial Details

FieldValue
Enrollment Target 737 participants
Start Date 2017-06-15
Est. Completion 2017-10-01

What the finished NCT03211897 record still lists

NCT03211897 is an observational study that tracks outcomes without assigning an intervention. The registered 737 participants enrollment target is mid-sized for trials with a published cap, above the 212-participant average among 5 other Agitation,Psychomotor trials with a reported enrollment target (248% higher).

The record links to 1 condition, with Agitation,Psychomotor appearing as the primary indexed condition, and to 4 interventions - of which Haloperidol Injection is the first listed.

NCT03211897 reports a single indexed study location in Minnesota.

Frequently Asked Questions

What is clinical trial NCT03211897 about?

NCT03211897 is a clinical study titled "Olanzapine, Haloperidol, Ziprasidone, Midazolam for Acute Undifferentiated Agitation". The goal of this research investigation is to conduct a prospective observational study of the comparative efficacy of haloperidol versus olanzapine versus midazolam versus ziprasidone for the treatment of acute undifferentiated agitation in the emergency department.

What is the current status of trial NCT03211897?

This trial is currently completed. The enrollment target is 737 participants. The study started on 2017-06-15. Estimated completion is 2017-10-01.

What conditions does trial NCT03211897 study?

This clinical trial studies the following conditions: Agitation,Psychomotor.

What interventions are being tested in trial NCT03211897?

The interventions under investigation include: Haloperidol Injection (DRUG), Ziprasidone Injection (DRUG), OLANZapine Injection (DRUG), Midazolam injection (DRUG).

Who is sponsoring clinical trial NCT03211897?

This trial is sponsored by Hennepin Healthcare Research Institute, which has 63 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03211897 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT03211897, the US trial registry maintained by the National Library of Medicine. NCT03211897 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.