Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
56 participants
INTERVENTIONAL
2012-12-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Haloperidol
Haloperidol 5mg intramuscular injection
Haloperidol
Valproate
Valproate single Infusion; 400 mg (weigh\<60 kg), 500 mg (weight\>60 Kg)
Valproate
Interventions
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Haloperidol
Valproate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aged 18 to 65 years
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Dr. Kamran Heydari
Assistant Professor of Emergency Medicine
Principal Investigators
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Kamran Heydari, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Emergency Medicine, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Locations
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Department of Emergency Medicine, Imam Hossein Hospital
Tehran, Tehran Province, Iran
Countries
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Other Identifiers
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MOH-021
Identifier Type: OTHER
Identifier Source: secondary_id
SB-021
Identifier Type: -
Identifier Source: org_study_id
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