Phase 4 N=72 Randomized Single-blind Treatment

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

Agitation

Bottom Line

View on ClinicalTrials.gov: NCT00457366 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: Primary: Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication. — -11.0; -11.5 score on a scale — p=>0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Quetiapine (Drug); Haloperidol (Drug); Lorazepam (Drug); Cogentin (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Southern California
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication.	-11.0; -11.5	>0.05

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00457366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.