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Haloperidol vs. Valproate in Agitation

Primary Purpose

Psychomotor Agitation

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Haloperidol
Valproate
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychomotor Agitation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Emergency Medicine, Imam Hossein Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Haloperidol

Valproate

Arm Description

Haloperidol 5mg intramuscular injection

Valproate single Infusion; 400 mg (weigh<60 kg), 500 mg (weight>60 Kg)

Outcomes

Primary Outcome Measures

Reduction in Agitated Behavior Scale (ABS) score
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.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2012
Last Updated
January 5, 2013
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01750541
Brief Title
Haloperidol vs. Valproate in Agitation
Official Title
Haloperidol vs. Valproate in the Management of Agitated Patients Presenting to the Emergency Department: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychomotor Agitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Haloperidol
Arm Type
Active Comparator
Arm Description
Haloperidol 5mg intramuscular injection
Arm Title
Valproate
Arm Type
Active Comparator
Arm Description
Valproate single Infusion; 400 mg (weigh<60 kg), 500 mg (weight>60 Kg)
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Other Intervention Name(s)
Haldol
Intervention Type
Drug
Intervention Name(s)
Valproate
Other Intervention Name(s)
Depakene
Primary Outcome Measure Information:
Title
Reduction in Agitated Behavior Scale (ABS) score
Description
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.
Time Frame
within the first 30 minutes of treatment onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamran Heydari, MD
Organizational Affiliation
Department of Emergency Medicine, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Emergency Medicine, Imam Hossein Hospital
City
Tehran
ZIP/Postal Code
1617763141
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Haloperidol vs. Valproate in Agitation

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