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Completed

NCT Number: NCT01750541

Haloperidol vs. Valproate in Agitation

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

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Key information

Conditions

Psychomotor Agitation Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Dyskinesias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Disorders Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Emergency Medicine, Imam Hossein Hospital

Tehran, Tehran Province, 1617763141, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Haloperidol

Drug

Other names: Haldol

Valproate

Drug

Other names: Depakene

Primary outcomes

  1. Reduction in Agitated Behavior Scale (ABS) score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Dec 17, 2012
Registry last updated
Jan 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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