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Haloperidol vs. Valproate in Agitation

Information source: Shahid Beheshti Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psychomotor Agitation

Intervention: Haloperidol (Drug); Valproate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Shahid Beheshti Medical University

Official(s) and/or principal investigator(s):
Kamran Heydari, MD, Principal Investigator, Affiliation: Department of Emergency Medicine, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Reduction in Agitated Behavior Scale (ABS) score


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


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

Locations and Contacts

Department of Emergency Medicine, Imam Hossein Hospital, Tehran 1617763141, Iran, Islamic Republic of
Additional Information

Starting date: December 2012
Last updated: January 5, 2013

Page last updated: August 23, 2015

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