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Rapid tranquillization of agitated or aggressive patients in an in-patient psychiatric setting: Pragmatic randomized double-blind trial of intramuscular olanzapine versus intramuscular haloperidol

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SLCTR Registration Number

SLCTR/2011/013

Date of Registration

28 Nov 2011

The date of last modification

Mar 03, 2019


Application Summary

Scientific Title of Trial

Rapid tranquillization of agitated or aggressive patients in an in-patient psychiatric setting: Pragmatic randomized double-blind trial of intramuscular olanzapine versus intramuscular haloperidol

Public Title of Trial

Study on rapid tranquilization: comparison of intramuscular olanzapine and intramuscular haloperidol

Disease or Health Condition(s) Studied

Psychiatric conditions

Scientific Acronym

None

Public Acronym

None

Brief title

None

Universal Trial Number

None

Any other number(s) assigned to the trial and issuing authority

EC-11-030 (Ethics Review Committee, Faculty of Medicine, University of Colombo)


Trial Details

What is the research question being addressed?

To compare the efficacy of two intramuscular drugs used for rapid tranquillization ?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Double blinded

Control

Active

Assignment

Parallel

Purpose

Treatment

Study Phase

Not Available

Intervention(s) planned

Eligible participants would be randomized to receive either intramuscular haloperidol (5-10 mg) or intramuscular olanzapine (10 mg). All doses would be at the discretion of the attending doctor and will be within the currently recommended therapeutic dose range

Inclusion criteria

  1. Age 18-65 years
    1. Patients admitted with acute agitation or already hospitalized and become agitated with a total score of Positive and Negative Symptoms Scale-Excited Component (PANSS-EC) >= 14 or at least one item with a score of >= 4 (If this requirement is not met at baseline and rapid tranquilization has not been given the patient could be re-evaluated in the subsequent 24 hours)
    2. Clear indication of intramuscular route of administration according to the attending doctor because of agitation, aggression, or violent behaviour
    3. Presence of good physical health confirmed by medical history and physical examination

Exclusion criteria

  1. Agitation primarily due to acute intoxication
  2. History of drug or alcohol dependence in the previous 8 weeks
  3. Use of benzodiazepines / other hypnotics/ oral or intramuscular antipsychotic in the 4 hours before study intervention
  4. Use of depot antipsychotic within one dose interval before study intervention
  5. Clinically significant acute or chronic pulmonary disease/ clinically significant hepatic, renal, gastroenterological, cardiovascular, neurological or hematological disease
  6. Pregnant or lactating females

Primary outcome(s)

1.

Positive and Negative Symptoms Scale – Excited Component (PANSS–EC)

 [

At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention

]
2.

Clinical Global Impression Scale (CGI)

 [

At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention

]
3.

Agitation Calmness Evaluation Scale (ACES)

 [

At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention

]
4.

Overt Aggression scale (OAS)

 [

At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention

]

Secondary outcome(s)

1.

Proportion of patients requiring medical attention due to continued agitation

 [

At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention

]
2.

Proportion of patients requiring physical restraining

 [

At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention

]
3.

Proportion of that needed additional medication

 [

At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention

]
4.

Extrapyramidal side effects with Simpson Angus Extrapyramidal symptom scale and Barnes akathisia scale

 [

At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention

]
5.

Vital signs (heart rate, respiratory rate,systolic and diastolic blood pressure)

 [

At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention

]

Target number/sample size

134

Countries of recruitment

Sri Lanka

Anticipated start date

2011-12-31

Anticipated end date

2012-01-31

Date of first enrollment

Date of study completion

Recruitment status

Pending

Funding source

None

Regulatory approvals


State of Ethics Review Approval

Status

Approved

Date of Approval

2011-07-21

Approval number

EC-11-030

Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Colombo
Institutional Address:No. 25, Kynsey Road, Colombo 00800 Sri Lanka
Telephone:+94-11-2695300 (Extension: 240)
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr Hiranya Wijesundara
Senior Registrar in Psychiatry
University Psychiatry Unit, National Hospital, Sri Lanka

0773420532

hiranya.w@gmail.com

Contact Person for Public Queries

Dr Hiranya Wijesundara
Senior Registrar in Psychiatry
University Psychiatry Unit, National Hospital, Sri Lanka

0773420532

hiranya.w@gmail.com

Primary study sponsor/organization

Dr Varuni de Silva,
Senior Lecturer
Department of Psychological Medicine, Faculty of Medicine, University of Colombo
0112691688

varunidesilva2@yahoo.co.uk

Secondary study sponsor (If any)

None





Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

No

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results


  • Trial Options