Haloperidol vs. Valproate in Agitation

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Psychomotor Agitation

Treatments: Drug: Valproate; Drug: Haloperidol

Study type: Interventional

Funder types: Other

Identifiers

NCT01750541

SB-021

MOH-021 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups

Haloperidol

Active Comparator group

Description:

Haloperidol 5mg intramuscular injection

Treatment:

Drug: Haloperidol

Valproate

Active Comparator group

Description:

Valproate single Infusion; 400 mg (weigh\<60 kg), 500 mg (weight\>60 Kg)

Treatment:

Drug: Valproate