Psychomotor AgitationPhase 3NCT01750541
Haloperidol vs. Valproate in Agitation
A Phase 3 study testing Haloperidol and Valproate in people with Psychomotor Agitation, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to compare the efficacy of haloperidol and valproate in management of people with agitation in emergency department Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psychomotor Agitation
- What is being tested?
- Haloperidol and Valproate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIran
- Study dates
- Dec 2012to Jan 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of psychomotor agitation
- aged 18 to 65 years
Who cannot join
- 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
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- Noticeable or suspected head trauma
- Previous history of neuroleptic malignant syndrome
- Receiving psychotropic medication, neuroleptic agents or cholinesterase inhibitors at the time of enrollment
Trial locations and contacts
1 site in 1 country.
Iran1 site
Department of Emergency Medicine, Imam Hossein Hospital
Tehran, Tehran Province, 1617763141
About this study
Official title: Haloperidol vs. Valproate in the Management of Agitated Patients Presenting to the Emergency Department: A Randomized Clinical Trial
The aim of this study is to compare the efficacy of haloperidol and valproate in management of people with agitation in emergency department
- Conditions
- Psychomotor Agitation
- Being tested
- Haloperidol, Valproate
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaloperidolDrug
Also called Haldol
ValproateDrug
Also called Depakene
| Study group | Role | What they receive |
|---|---|---|
| Haloperidol | Active comparator | Haloperidol 5mg intramuscular injection Receives: Drug: Haloperidol |
| Valproate | Active comparator | Valproate single Infusion; 400 mg (weigh<60 kg), 500 mg (weight>60 Kg) Receives: Drug: Valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within the first 30 minutes of treatment onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychomotor AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kamran Heydari, Shahid Beheshti University of Medical Sciences
- Investigators
- Kamran Heydari, MD, Principal investigator, Department of Emergency Medicine, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750541
- Sponsor's protocol ID
- SB-021
- Other IDs
- MOH-021
- Status last verified
- Jan 2013
- First submitted
- 7 Dec 2012
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haloperidol vs. Valproate in the Management of Agitated Patients Presenting to the Emergency Department: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01750541
- Acronym / sponsor ID
- SB-021
- Conditions
- Psychomotor Agitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the efficacy of haloperidol and valproate in management of people with agitation in emergency department
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haloperidol | Active comparator | Drug: HaloperidolHaloperidol 5mg intramuscular injection |
| Valproate | Active comparator | Drug: ValproateValproate single Infusion; 400 mg (weigh<60 kg), 500 mg (weight>60 Kg) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of psychomotor agitation
- aged 18 to 65 years
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HaloperidolAlso: Haldol | Drug | Haloperidol |
| ValproateAlso: Depakene | Drug | Valproate |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamran Heydari, MD principal investigator
Department of Emergency Medicine, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Haloperidol and Valproate in people with Psychomotor Agitation, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Agitated Behavior Scale (ABS) score (time frame: within the first 30 minutes of treatment onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2013.