Haloperidol vs. Valproate in Agitation

Haloperidol vs. Valproate in the Management of Agitated Patients Presenting to the Emergency Department: A Randomized Clinical Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01750541

Enrollment

Registered

2012-12-17

Start date

2012-12-31

Completion date

2013-01-31

Last updated

2013-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychomotor Agitation

Brief summary

The aim of this study is to compare the efficacy of haloperidol and valproate in management of people with agitation in emergency department

Interventions

DRUGHaloperidol

DRUGValproate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of psychomotor agitation * aged 18 to 65 years

Exclusion criteria

* Pregnant patients * Severe liver disease * History of drug (haloperidol/valproate) allergy * Readily amendable causes for the agitation (hypoxemia or hypoglycemia) * Hypotension (systolic blood pressure (SBP) ≤ 90 mm Hg) * Known history of liver disease or uncontrolled diabetes * Noticeable or suspected head trauma * Previous history of neuroleptic malignant syndrome * Receiving psychotropic medication, neuroleptic agents or cholinesterase inhibitors at the time of enrollment

Design outcomes

Primary

Measure	Time frame	Description
Reduction in Agitated Behavior Scale (ABS) score	within the first 30 minutes of treatment onset	Patients were rated before medication administration and within 30 minutes afterwards according to Agitated Behavior Scale (ABS) score. Any statistically significant change in ABS score consider as positive effect of either intervention.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026