Rapid safe tranquillisation for acutely disturbed people attending public psychiatric emergency clinics in Rio de Janeiro

Not Applicable

Completed

• Conditions: Serious mental illnesses combined with overt aggression or violence; Mental and Behavioural Disorders; Aggression or violence in mental illness

• Registration Number: ISRCTN44153243
• Lead Sponsor: Oswaldo Cruz Foundation (Brazil)

Brief Summary

1. 2002 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/12383353 2. 2003 results in: https://www.ncbi.nlm.nih.gov/pubmed/14512476 (added 21/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-03-08
• Study Completion: 2004-01-01
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 301

Inclusion Criteria

1. It is clear that they need acute intramuscular sedation because of disturbed and dangerous behaviour thought to be due to serious mental illness; and
2. The clinician is uncertain about the benefits and risks of the comparator medications.

Exclusion Criteria

People are not eligible for trial entry if the clinician believes that one treatment represents an additional risk for the patient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tranquillisation at 20 minutes.

Secondary Outcome Measures

Name	Time	Method
Effects on other measures of morbidity, recorded at 24 hours and two weeks.