Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000033044
Ethics application status
Approved
Date submitted
4/01/2010
Date registered
12/01/2010
Date last updated
21/02/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Rapid tranquillisation for agitated patients in emergency psychiatric rooms.
Scientific title
Rapid tranquillisation for agitated patients in emergency psychiatric rooms: a randomised trial of olanzapine, ziprasidone, haloperidol plus promethazine, haloperidol plus midazolam and haloperidol alone for reduction in agitation.
Secondary ID [1] 1227 0
None
Universal Trial Number (UTN)
U1111-1113-1218
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Agitation in psychiatric emergencies 256465 0
Agressiviness in psychiatric emergencies 256500 0
Condition category
Condition code
Mental Health 256634 256634 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One hundred fifty subjects in agitation secundary to psychotic or bipolar disorder will be selected randomly for one of five rapid tranquilization options by intramuscular administration at baseline: olanzapine 10mg, ziprasidone 20mg, haloperidol 5mg plus midazolam 15mg, haloperidol 5mg plus promethazine 50mg and haloperidol 5mg alone. They will be revaluated after one hour, two hours, four hours, six hours and twelve hours after first medication by Overt Agitation Severity Scale, Overt Agression Scale and Ramsay Sedation Scale after 1 hours, 2 hours, 4 hours, 6 hours and 12 hours after first administration. When necessary aditional medication haloperidol 5mg plus promethazine 50mg will be used for all groups. This protocol will used for 12 hours.
Intervention code [1] 255752 0
Treatment: Drugs
Comparator / control treatment
Haloperidol 5mg alone.
Control group
Active

Outcomes
Primary outcome [1] 257524 0
Overt Agitation Severity Scale
Timepoint [1] 257524 0
Baseline
1 hour
2 hours
4 hours
6 hours
12 hours (Endpoint)
Primary outcome [2] 257525 0
Overt Agression Scale
Timepoint [2] 257525 0
Baseline
1 hour
2 hours
4 hours
6 hours
12 hours (Endpoint)
Primary outcome [3] 257526 0
Ramsay Sedation Scale. This scale measure the sedation level of each medication.
Timepoint [3] 257526 0
Baseline
1 hour
2 hours
4 hours
6 hours
12 hours (Endpoint)
Secondary outcome [1] 262752 0
Side effects evaluated by a trained psychiatrist and register in the archives. The mean side effects expected are: excessive sedation (Ramsay Scale leve more than 3 points), hypotention, dystonia, parkinsonism, acathisia, bradicardia.
Timepoint [1] 262752 0
Baseline
1 hour
2 hours
4 hours
6 hours
12 hours (Endpoint)

Eligibility
Key inclusion criteria
Any subject in agitation, between 18 and 50 years of age, by bipolar or psychotic disorder by Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR criteria), Overt Agitation Severity Scale Total Score (OASS) equal or under 20 and Overt Aggressive Scale (OAS) with equal or less 4 positive itens.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Disorders due to drug abuse, organic disorder, anxiety or personality disorder by Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR criteria), no concordance to research, incapable to proceed all steps and not stable clinical disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patient admitted in Psychiatric Emergency Room of Irmandade da Santa Casa de Sao Paulo in agitation and that meet inclusion criteria will be evaluated by a trainee psychiatrist to verify if there is rapid tranquilization demand. Inclusion criteria was determined by another psychiatrist. If there is demand subject will receive one of the five options cited. Allocation will be done by numbered containers. Studied medications will be packaged in identical color-coded boxes. After initial dose only haloperidol plus prometazine will be used accordily to clinician juggement. If a subject need another intervention he will immediately removed from study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each drug regimen medication will be selected in blocks of five subjects and will be distributed in this order: olanzapine, ziprasidone, haloperidol plus prometazine, haloperidol plus midazolam and haloperidol. This selection will be realized until the total number (150 subjects) be reached. It will used permuted block randomisation. Patients will be assessed by two psychiatrists. They will all masked with regard to the patient's treatment assignment and patients will be instructed not to reveal their current treatment to these investigators.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 2383 0
Brazil
State/province [1] 2383 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 256235 0
Hospital
Name [1] 256235 0
Irmandade da Santa Casa de Misericordia de Sao Paulo
Country [1] 256235 0
Brazil
Primary sponsor type
University
Name
Federal University of Tocantins
Address
Medicine
Av: NS 15 ALC NO 14, 109 Norte, Caixa Postal 114 - 77001-090
Palmas - TO
Country
Brazil
Secondary sponsor category [1] 251567 0
None
Name [1] 251567 0
Address [1] 251567 0
Country [1] 251567 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258328 0
Comite de Etica em Pesquisa em Seres Humanos
Ethics committee address [1] 258328 0
Rua Santa isabel, 305, Quarto andar CEP 01221-010 - Sao Paulo - SP
Ethics committee country [1] 258328 0
Brazil
Date submitted for ethics approval [1] 258328 0
01/04/2008
Approval date [1] 258328 0
01/06/2008
Ethics approval number [1] 258328 0
CEP 150/08 and CEP 157/08

Summary
Brief summary
Agitated or violent behavior, mostly as a result of serious mental illness and substance misuse constitutes around 10% of the reasons for use of emergency services. The drugs used in such situations should calm patients safely and swiftly. Guidelines, however, are usually statements of consensus and differ on which drugs to use. Some of the new generation antipsychotics are really not only for oral use but also for parenteral use such as olanzapine and ziprasidone. These medications means an advance in rapid manage of acute behavior alterations. By the way, knowledge about antipsychotics profile in agitation and aggressive behavior is limited and few studies compare several drugs in rapid tranquilization. The objective of this study is to compare five options of parenteral (intramuscular) antipsychotics, including olanzapine, ziprasidone, haloperidol, haloperidol plus promethazine and haloperidol plus midazolam as first medication in agitation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30656 0
Address 30656 0
Country 30656 0
Phone 30656 0
Fax 30656 0
Email 30656 0
Contact person for public queries
Name 13903 0
Leonardo Baldacara
Address 13903 0
Av: NS 15 ALC NO 14, 109 Norte, Caixa Postal 114 - 77001-090
Palmas - TO
Country 13903 0
Brazil
Phone 13903 0
55-63-3232-8158
Fax 13903 0
55-63-3228-1807
Email 13903 0
leonardobaldassara@gmail.com
Contact person for scientific queries
Name 4831 0
Leonardo Baldacara
Address 4831 0
Av: NS 15 ALC NO 14, 109 Norte, Caixa Postal 114 - 77001-090
Palmas - TO
Country 4831 0
Brazil
Phone 4831 0
55-63-32328158
Fax 4831 0
55-63-32281807
Email 4831 0
leonardobaldassara@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
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