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Haloperidol vs. Valproate in Agitation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Kamran Heydari, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01750541
First received: December 7, 2012
Last updated: January 5, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750541

Locations
Iran, Islamic Republic of
Department of Emergency Medicine, Imam Hossein Hospital
Tehran, Iran, Islamic Republic of, 1617763141
Sponsors and Collaborators
Shaheed Beheshti Medical University
Investigators
Principal Investigator: Kamran Heydari, MD Department of Emergency Medicine, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
  More Information

No publications provided

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
Study First Received: December 7, 2012
Last Updated: January 5, 2013
Health Authority: Iran: Ministry of Health

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Valproic Acid
Haloperidol
Haloperidol decanoate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipsychotic Agents
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 21, 2013