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Haloperidol vs. Valproate in Agitation

This study has been completed.
Information provided by (Responsible Party):
Dr. Kamran Heydari, Shaheed Beheshti Medical University Identifier:
First received: December 7, 2012
Last updated: January 5, 2013
Last verified: January 2013
The aim of this study is to compare the efficacy of haloperidol and valproate in management of people with agitation in emergency department

Condition Intervention Phase
Psychomotor Agitation
Drug: Haloperidol
Drug: Valproate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • Reduction in Agitated Behavior Scale (ABS) score [ Time Frame: within the first 30 minutes of treatment onset ] [ Designated as safety issue: Yes ]
    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.

Enrollment: 56
Study Start Date: December 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01750541

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
Principal Investigator: Kamran Heydari, MD Department of Emergency Medicine, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
  More Information

Responsible Party: Dr. Kamran Heydari, Assistant Professor of Emergency Medicine, Shaheed Beheshti Medical University Identifier: NCT01750541     History of Changes
Other Study ID Numbers: SB-021  MOH-021 
Study First Received: December 7, 2012
Last Updated: January 5, 2013
Health Authority: Iran: Ministry of Health

Additional relevant MeSH terms:
Psychomotor Agitation
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Haloperidol decanoate
Valproic Acid
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 processed this record on October 26, 2016