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NCT00457366 · ClinicalTrials.gov registry record · Phase 4
A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room
A Phase 4 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 4
- Development phase
- 72
- Enrollment target
NCT00457366: Completed Phase 4 study, sponsored by University of Southern California.
NCT00457366 is a Phase 4 study that has completed, run by University of Southern California. The registered enrollment target is 72 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00457366, a Phase 4 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 72 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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 (Monto
Interventions
- DRUG Haloperidol
- DRUG Quetiapine
- DRUG Lorazepam
- DRUG Cogentin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2006-05 |
| Est. Completion | 2009-05 |
| Phase | Phase 4 |
What the finished NCT00457366 record still lists
NCT00457366 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 4 interventions - of which Haloperidol is the first listed.
NCT00457366 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00457366 about?
NCT00457366 is a clinical study titled "A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room". 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 ac...
What is the current status of trial NCT00457366?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2006-05. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00457366?
The interventions under investigation include: Haloperidol (DRUG), Quetiapine (DRUG), Lorazepam (DRUG), Cogentin (DRUG).
Who is sponsoring clinical trial NCT00457366?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00457366's enrollment target sits among peer trials
72 1035th of 2000 higher than 961 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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