Agitation,PsychomotorOvMNCT03899506
Olanzapine Versus Midazolam for Agitation
An observational study of Agitation,Psychomotor, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial summary
The goal of this research investigation is to conduct a prospective observation of the comparative efficacy of midazolam versus olanzapine for the treatment of acute undifferentiated agitation in the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Agitation,Psychomotor
- What is being tested?
- Olanzapine and Midazolam
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2018to 16 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ED patients with agitation who receive a medication per protocol at the discretion of ED providers
Who may be able to join
- Emergency Department patients
- Patients 18 years and older
- Patients with acute undifferentiated agitation requiring chemical sedation at the discretion of the attending emergency physician will be observed.
- Patients meeting these criteria who receive medications in the ED will be observed by research staff, evaluating efficacy and safety of the administered medication.
Who cannot join
- There are no exclusion criteria per se as this is only observational research. The decision to administer the medication is at the discretion of the physician. Research protocols are only such that we are observing the efficacy and safety, which coincides the quality improvement purposes of this clinical protocol. Patients will be provided an Information Sheet and can opt to have their data removed.
- Patients who are prisoners, children, will NOT have their data collected
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: Prospective Observational Investigation of Olanzapine Versus Midazolam for the Treatment of Acute Undifferentiated Agitation in the Emergency Department
The goal of this research investigation is to conduct a prospective observation of the comparative efficacy of midazolam versus olanzapine for the treatment of acute undifferentiated agitation in the emergency department.
Read the detailed description
The goal of this research investigation is to conduct a prospective observation of the comparative efficacy of midazolam versus olanzapine for the treatment of acute undifferentiated agitation in the emergency department.
In the summer of 2017, the ED implemented a treatment protocol as a quality improvement initiative. The investigators performed observational research on this protocol and identified that haloperidol and ziprasidone were inferior to midazolam and olanzapine for treating agitation in our Department.
The comparison between olanzapine and midazolam, however, was inconclusive. It is possible that this is due to inadequate power, so the question of whether olanzapine or midazolam is superior is still unknown.
Because the department continues to strive to achieve the best care for this patient population, in the Summer of 2018 the ED is going to initiate a second ED treatment protocol of olanzapine and midazolam, based on the results of our 2017 protocol.
All patients requiring chemical sedation for will receive olanzapine as the initial treatment for agitation for 6 weeks, followed by midazolam as the initial treatment for agitation for 6 weeks. These patients will be observed by research staff.
This is a clinical care quality improvement protocol. The clinical protocol is not research. The research component is the observation of this clinical care protocol.
- Conditions
- Agitation,Psychomotor
- Being tested
- Olanzapine, Midazolam
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Patients receiving Olanzapine per the ED protocol
MidazolamDrug
Patients receiving Midazolam per the ED protocol
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Patients receiving 10 mg IM Olanzapine per the ED protocol Receives: Drug: Olanzapine | |
| Midazolam | Patients receiving 5 mg IM Midazolam per the ED protocol Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Adequately Sedated at 15 minutes
Proportion of patients who achieve an AMSS score of < 1 at 15 minutes
Measured: 15 minutes
Secondary outcomes (4)
Proportion of Patients Adequately Sedated at 30 minutes
Proportion of patients who achieve an AMSS score of < 1 at 30 minutes
Measured: 30 minutes
Proportion of Patients Adequately Sedated at 60 minutes
Proportion of patients who achieve an AMSS score of < 1 at 60 minutes
Measured: 60 minutes
Proportion of Patients Adequately Sedated at 120 minutes
Proportion of patients who achieve an AMSS score of < 1 at 120 minutes
Measured: 120 minutes
Safety Events
Proportion of patients who experience respiratory depression, hypotension, extrapyramidal side effects
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start18 Jun 2018
- Primary completion16 Jul 2018
- Study completion16 Jul 2018
Why it stopped: Investigator Voluntary Pause
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Agitation,PsychomotorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Klein, Hennepin Healthcare Research Institute
- Investigators
- Lauren Klein, MD, Principal investigator, Hennepin County Medical Center, Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899506
- Sponsor's protocol ID
- HSR #18-4521
- Acronym
- OvM
- Status last verified
- May 2019
- First submitted
- 28 Jun 2018
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Investigation of Olanzapine Versus Midazolam for the Treatment of Acute Undifferentiated Agitation in the Emergency Department
- ClinicalTrials.gov ID
- NCT03899506
- Acronym / sponsor ID
- OvM / HSR #18-4521
- Conditions
- Agitation,Psychomotor
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator Voluntary Pause
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 16 Jul 2018 (actual)
- Study completion
- 16 Jul 2018 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research investigation is to conduct a prospective observation of the comparative efficacy of midazolam versus olanzapine for the treatment of acute undifferentiated agitation in the emergency department.
Detailed description
The goal of this research investigation is to conduct a prospective observation of the comparative efficacy of midazolam versus olanzapine for the treatment of acute undifferentiated agitation in the emergency department.
In the summer of 2017, the ED implemented a treatment protocol as a quality improvement initiative. The investigators performed observational research on this protocol and identified that haloperidol and ziprasidone were inferior to midazolam and olanzapine for treating agitation in our Department.
The comparison between olanzapine and midazolam, however, was inconclusive. It is possible that this is due to inadequate power, so the question of whether olanzapine or midazolam is superior is still unknown.
Because the department continues to strive to achieve the best care for this patient population, in the Summer of 2018 the ED is going to initiate a second ED treatment protocol of olanzapine and midazolam, based on the results of our 2017 protocol.
All patients requiring chemical sedation for will receive olanzapine as the initial treatment for agitation for 6 weeks, followed by midazolam as the initial treatment for agitation for 6 weeks. These patients will be observed by research staff.
This is a clinical care quality improvement protocol. The clinical protocol is not research. The research component is the observation of this clinical care protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | – | Drug: OlanzapinePatients receiving 10 mg IM Olanzapine per the ED protocol |
| Midazolam | – | Drug: MidazolamPatients receiving 5 mg IM Midazolam per the ED protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ED patients with agitation who receive a medication per protocol at the discretion of ED providers
Key inclusion criteria (4 listed)
- Emergency Department patients
- Patients 18 years and older
- Patients with acute undifferentiated agitation requiring chemical sedation at the discretion of the attending emergency physician will be observed.
- Patients meeting these criteria who receive medications in the ED will be observed by research staff, evaluating efficacy and safety of the administered medication.
Key exclusion criteria (2 listed)
- There are no exclusion criteria per se as this is only observational research. The decision to administer the medication is at the discretion of the physician. Research protocols are only such that we are observing the efficacy and safety, which coincides the quality improvement purposes of this clinical protocol. Patients will be provided an Information Sheet and can opt to have their data removed.
- Patients who are prisoners, children, will NOT have their data collected
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlanzapinePatients receiving Olanzapine per the ED protocol | Drug | Olanzapine |
| MidazolamPatients receiving Midazolam per the ED protocol | Drug | Midazolam |
Primary outcome
Proportion of Patients Adequately Sedated at 15 minutes
Time frame: 15 minutes
Proportion of patients who achieve an AMSS score of < 1 at 15 minutes
4 secondary outcomes
Proportion of Patients Adequately Sedated at 30 minutes
Time frame: 30 minutes
Proportion of Patients Adequately Sedated at 60 minutes
Time frame: 60 minutes
Proportion of Patients Adequately Sedated at 120 minutes
Time frame: 120 minutes
Safety Events
Time frame: 120 minutes
Results and safety
The study was stopped early (reason given: Investigator Voluntary Pause). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Klein, MD principal investigator
Hennepin County Medical Center, Minneapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Agitation,Psychomotor, run by Hennepin Healthcare Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator Voluntary Pause). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Adequately Sedated at 15 minutes (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.