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Haloperidol vs. Valproate in Agitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01750541
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : January 8, 2013
Information provided by (Responsible Party):
Dr. Kamran Heydari, Shahid Beheshti University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Psychomotor Agitation Drug: Haloperidol Drug: Valproate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Haloperidol vs. Valproate in the Management of Agitated Patients Presenting to the Emergency Department: A Randomized Clinical Trial
Study Start Date : December 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Haloperidol
Haloperidol 5mg intramuscular injection
Drug: Haloperidol
Other Name: Haldol

Active Comparator: Valproate
Valproate single Infusion; 400 mg (weigh<60 kg), 500 mg (weight>60 Kg)
Drug: Valproate
Other Name: Depakene

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01750541

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Iran, Islamic Republic of
Department of Emergency Medicine, Imam Hossein Hospital
Tehran, Iran, Islamic Republic of, 1617763141
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
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Principal Investigator: Kamran Heydari, MD Department of Emergency Medicine, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
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Responsible Party: Dr. Kamran Heydari, Assistant Professor of Emergency Medicine, Shahid Beheshti University of Medical Sciences Identifier: NCT01750541    
Other Study ID Numbers: SB-021
MOH-021 ( Other Identifier: The Ministry of Health and Medical Education (MOHME) )
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Psychomotor Agitation
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Valproic Acid
Haloperidol decanoate
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Enzyme Inhibitors
GABA Agents
Antimanic Agents