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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.
ClinicalTrials.gov Identifier: NCT01750541
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : January 8, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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
Primary Completion Date : December 2012
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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.


Eligibility Criteria

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
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT01750541


Locations
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
Investigators
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
ClinicalTrials.gov Identifier: NCT01750541     History of Changes
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:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Haloperidol
Haloperidol decanoate
Valproic Acid
Antiemetics
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
Anticonvulsants
Enzyme Inhibitors
GABA Agents
Antimanic Agents