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Trial · NCT00457366

A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room

NCT00457366, Phase 4, Completed, University of Southern California; results first posted 2019-07-05

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room. Trials, record NCT00457366. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00457366

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room
NCT number
NCT00457366
Status
Completed
Phases
Phase 4
Enrollment
72 participants, actual
Lead sponsor
University of Southern California
Conditions
Agitation
Interventions
Quetiapine, Haloperidol, Lorazepam, Cogentin
First posted
2007-04-06
Last updated
2019-07-26
Results first posted
2019-07-05

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication.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).

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication.Two hours
34 patients received the Cocktail, but 4 of these were excluded from the analysis because they had only demographic data and no clinical outcome data. A total of 38 patients received Quetiapine; all were included in the analysis.
score on a scaleLEAST_SQUARES_MEAN

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication.Cocktail-11.0Standard Error 0.82score on a scale
Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication.Quetiapine-11.5Standard Error 0.69score on a scale

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDQuetiapine40
Overall StudySTARTEDCocktail Consisting of Haloperidol, Lorazepam, Cogentin32
Overall StudyCOMPLETEDQuetiapine40
Overall StudyCOMPLETEDCocktail Consisting of Haloperidol, Lorazepam, Cogentin32
Overall StudyNOT COMPLETEDQuetiapine0
Overall StudyNOT COMPLETEDCocktail Consisting of Haloperidol, Lorazepam, Cogentin0

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityQuetiapine
Total, all-cause mortalityCocktail
Total, other adverse eventsQuetiapine040
Total, other adverse eventsCocktail032
Total, serious adverse eventsQuetiapine040
Total, serious adverse eventsCocktail032

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Quetiapine vs Cocktail: serious adverse events

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00457366

GET https://conductscience.org/api/trials/v1/NCT00457366/registered