Condition category
Mental and Behavioural Disorders
Date applied
29/04/2002
Date assigned
29/04/2002
Last edited
02/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Prathap Tharyan

ORCID ID

Contact details

Department of Psychiatry Unit II
Mental Health Center
Christian Medical College
Bagayam Vellore
632 002
India
+91 (416) 262603 ext 4259
dralexander_in@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

TREC-INDIA (Tranquilizacao Rapida-Ensaio Clinico; translated from Portuguese - 'Rapid Tranquillisation-Clinical Trial')

Study hypothesis

To compare interventions commonly used for controlling agitation or violence in people with serious psychiatric disorders.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Serious mental illnesses combined with overt aggression or agitation

Intervention

1. Haloperidol (up to 10 mg IM) with promethazine (up to 50 mg IM)
2. Lorazepam (4 mg IM)

Doses are not fixed and are at the discretion of the attending doctors.

Intervention type

Drug

Phase

Not Specified

Drug names

Lorazepam, Haloperidol, Promethazine

Primary outcome measures

1. Tranquil or asleep by 4 hours
2. The time of onset of tranquillisation and/or sleep

Participants were considered to be tranquil when they were calm and not exhibiting agitated, aggressive or dangerous behaviour. Patients were considered to be asleep if, on inspection, they appeared to be sound asleep and were not aroused by ambient disturbances.

Secondary outcome measures

These assessments were conducted only on participants who were awake, as extrapyramidal symptoms are usually not apparent during sleep or, in the case of dystonia or akathisia, are likely to prevent sleep:
1. Clinical Global Impression – Severity (CGI–S) scale at entry
2. CGI–Improvement (CGI–I) scale with respect to aggression and violence
3. Simpson–Angus extrapyramidal side-effects rating scale
4. Barnes Akathisia Scale
5. Any other clinically important adverse effects, especially dystonia

Other outcomes within the first 4 hours were:
6. The use of additional medication for control of agitated or aggressive behaviour
7. The use of physical restraints
8. The need for further medical attention and numbers absconding

Participants were also followed up 2 weeks later to check for adverse effects or adverse outcomes and compliance with oral medication.

Overall trial start date

01/01/2002

Overall trial end date

31/12/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Patients need acute intramuscular sedation because of disturbed and dangerous behaviour as decided by the attending physician.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

200

Participant exclusion criteria

1. The clinician believes that one of the two treatments represents an additional risk for the patient
2. Feels that one of the two treatments is definitely indicated for a given patient

Recruitment start date

01/01/2002

Recruitment end date

31/12/2002

Locations

Countries of recruitment

India

Trial participating centre

Department of Psychiatry Unit II
Bagayam Vellore
632 002
India

Sponsor information

Organisation

Christian Medical College and Hospital (India)

Sponsor details

Bagayam
Vellore
632002
India

Sponsor type

Hospital/treatment centre

Website

http://www.cmch-vellore.edu/

Funders

Funder type

Hospital/treatment centre

Funder name

Christian Medical College and Hospital (India) - Fluid Research Grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Cochrane Schizophrenia Group (CSG) (UK) - supported with funding for sundries

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The doctors and nurses of Vellore freely gave support, enthusiasm and skill.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=15231557&dopt=AbstractPlus

Publication citations

  1. Results

    Alexander J, Tharyan P, Adams C, John T, Mol C, Philip J, Rapid tranquillisation of violent or agitated patients in a psychiatric emergency setting. Pragmatic randomised trial of intramuscular lorazepam v. haloperidol plus promethazine., Br J Psychiatry, 2004, 185, 63-69.

Additional files

Editorial Notes