AgitationPhase 4NCT00457366
A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room
A Phase 4 study testing Quetiapine, Haloperidol and Lorazepam in people with Agitation, run by University of Southern California at 1 site in United States.
Trial summary
In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Agitation
- What is being tested?
- Quetiapine, Haloperidol and Lorazepam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to May 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- English or Spanish speaking patients
- Provision of written informed consent-English and Spanish
- Males and females age 18 to 60 years. Females who are pregnant by inspection should not be included.
- Provision at diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV) criteria for Axis I documented who present in an agitated state. PANSS-EC score should be >15.
- Ability, in the treating physician's opinion, to co-operate with taking oral medication
Who cannot join
- Pregnant females who will thus receive routine care in the treating physician's opinion
- Unstable medical illness
- Withdrawal stage from any illicit drugs
- Psychosis that prohibits participation in trial
- Females of childbearing age where pregnancy cannot be confirmed or denied by screening
- Patients who required continued intervention or prolonged restraint
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles County Hospital
Los Angeles, California, 90033
About this study
Official title: A Comparison Study of the Efficacy of a Rapid Titration of Quetiapine and Haloperidol in Agitated Adults in an Emergency Setting.
In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. However, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients as well as more likely to cause EPS (extrapyramidal symptoms). Of late in our emergency room, we started using high dose Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising results.
Read the detailed description
In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. However, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients as well as more likely to cause EPS (extrapyramidal symptoms). Of late in our emergency room, we started using high dose Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising results.
This study is designed to compare the efficacy and safety of Quetiapine with the routine "cocktail for treatment of agitation.
The primary purpose of this study is to determine the efficacy and safety of Quetiapine by using high dose Quetiapine (300 mg) PO to treat agitated patients in the psychiatric emergency room.
The secondary purpose is to test the immediate effect on agitation caused by illicit drug abuse or the alcohol abuse.
- Conditions
- Agitation
- Being tested
- Quetiapine, Haloperidol, Lorazepam, Cogentin
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
Also called no other name
Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary up to a maximum dose of Quetiapine 600mg PO QD
HaloperidolDrug
Also called no other names
given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary
LorazepamDrug
Also called no other name
given in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary.
CogentinDrug
Also called no other name
given in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary.
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine | Active comparator | Quetiapine is being used in an ER setting on agitated patients, being administered orally. Receives: Drug: Quetiapine |
| Haloperidol | Active comparator | "Haloperidol" is being used in an ER setting on agitated patients, administered IM. This is being used in combination with lorazepam and cogentin. We are comparing the use of this "cocktail" to quetiapine alone. Receives: Drug: Haloperidol |
| Lorazepam | Active comparator | "Lorazepam" is being used in an ER setting on agitated patients, administered IM.This is being used in combination with haloperidol, and cogentin. We are comparing the use of this "cocktail" to quetiapine alone. Receives: Drug: Lorazepam |
| Cogentin | Active comparator | "Cogentin" is being used in an ER setting on agitated patients, administered IM.
This is being used in combination with haloperidol, and lorazepam. We are comparing the use of this "cocktail" to quetiapine alone. Receives: Drug: Cogentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication.
The PANSS-EC is the Positive and Negative Syndrome Score - Excited Component, which includes 5 items (excitement, hostility, tension, uncooperative, poor impulse control), which are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients with different psychiatric pathologies (Montoya, A; Villadares, A; Lizan, L, et al., 2011).
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startMay 2006
- Primary completionAug 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgitationStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- George M Simpson, MD, Principal investigator, USC+LAC Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457366
- Sponsor's protocol ID
- HS-05-00331
- Status last verified
- Apr 2017
- First submitted
- 4 Apr 2007
- Last updated
- 26 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study of the Efficacy of a Rapid Titration of Quetiapine and Haloperidol in Agitated Adults in an Emergency Setting.
- ClinicalTrials.gov ID
- NCT00457366
- Acronym / sponsor ID
- HS-05-00331
- Conditions
- Agitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- May 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 6 Apr 2007 (estimated)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. However, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients as well as more likely to cause EPS (extrapyramidal symptoms). Of late in our emergency room, we started using high dose Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising results.
Detailed description
In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. However, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients as well as more likely to cause EPS (extrapyramidal symptoms). Of late in our emergency room, we started using high dose Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising results.
This study is designed to compare the efficacy and safety of Quetiapine with the routine "cocktail for treatment of agitation.
The primary purpose of this study is to determine the efficacy and safety of Quetiapine by using high dose Quetiapine (300 mg) PO to treat agitated patients in the psychiatric emergency room.
The secondary purpose is to test the immediate effect on agitation caused by illicit drug abuse or the alcohol abuse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Quetiapine | Active comparator | Drug: QuetiapineQuetiapine is being used in an ER setting on agitated patients, being administered orally. |
| Haloperidol | Active comparator | Drug: Haloperidol"Haloperidol" is being used in an ER setting on agitated patients, administered IM. This is being used in combination with lorazepam and cogentin. We are comparing the use of this "cocktail" to quetiapine alone. |
| Lorazepam | Active comparator | Drug: Lorazepam"Lorazepam" is being used in an ER setting on agitated patients, administered IM.This is being used in combination with haloperidol, and cogentin. We are comparing the use of this "cocktail" to quetiapine alone. |
| Cogentin | Active comparator | Drug: Cogentin"Cogentin" is being used in an ER setting on agitated patients, administered IM. This is being used in combination with haloperidol, and lorazepam. We are comparing the use of this "cocktail" to quetiapine alone. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- English or Spanish speaking patients
- Provision of written informed consent-English and Spanish
- Males and females age 18 to 60 years. Females who are pregnant by inspection should not be included.
- Provision at diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV) criteria for Axis I documented who present in an agitated state. PANSS-EC score should be >15.
- Ability, in the treating physician's opinion, to co-operate with taking oral medication
Key exclusion criteria (6 listed)
- Pregnant females who will thus receive routine care in the treating physician's opinion
- Unstable medical illness
- Withdrawal stage from any illicit drugs
- Psychosis that prohibits participation in trial
- Females of childbearing age where pregnancy cannot be confirmed or denied by screening
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 |
|---|---|---|
| QuetiapineAlso: no other nameQuetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary up to a maximum dose of Quetiapine 600mg PO QD | Drug | Quetiapine |
| HaloperidolAlso: no other namesgiven in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary | Drug | Haloperidol |
| LorazepamAlso: no other namegiven in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary. | Drug | Lorazepam |
| CogentinAlso: no other namegiven in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary. | Drug | Cogentin |
Primary outcome
Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication.
Time frame: Two hours
The PANSS-EC is the Positive and Negative Syndrome Score - Excited Component, which includes 5 items (excitement, hostility, tension, uncooperative, poor impulse control), which are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients with different psychiatric pathologies (Montoya, A; Villadares, A; Lizan, L, et al., 2011).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Lactium Premedication to Prevent Emergence Agitation
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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.
George M Simpson, MD principal investigator
USC+LAC Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quetiapine, Haloperidol and Lorazepam in people with Agitation, run by University of Southern California 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 26 Jul 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication. (time frame: Two hours). 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 26 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.