TREC‐Vellore‐III.

Trial name or title	Rapid tranquillization of violent or agitated patients in a psychiatric setting: pragmatic, randomised, allocation concealed, participant and assessor blinded trial of intramuscular zuclopenthixol acetate versus intramuscular haloperidol plus promethazine
Methods	Allocation: randomised, permuted block randomisations. Blinding: participant and outcome assessor blinding. Duration: 14 days. Setting: emergency services of psychiatric department in South India
Participants	Diagnosis: ICD‐10 diagnosis of F10, F20‐29, F30‐39, and F60‐62 presenting agitation and aggression. N=350. Age: adults between 18 and 65 years. History: agitation and violent behaviours requiring tranquillisation presenting in emergency
Interventions	Haloperidol plus promethazine IM: dose 10 mg haloperidol + dose 50 mg promethazine. N=100. Zuclopenthixol acetate IM: dose 100 mg. N=100.
Outcomes	Tranquil or asleep: by 30 mins, 120 mins, 24 hours, 48 hours, and 2 weeks. Specific behaviours: other episodes of aggression over 2 weeks. Global effects: use of additional medication, use of restraints/seclusion, needing extra visits from the doctor, refusing oral medication, CGI‐I, and absconding. Service outcomes: hospital discharge. Adverse effects: serious adverse effects over 48 hours, distonic and extrapyramidal symptoms. Leaving the study early. Economic: costs of interventions
Starting date	01/07/2014
Contact information	Name: Dr Prathap Tharyan. Designation: Professor. Affliation: Christian Medical College. Address: Department of Psychiatry. CMC Vellore. Bagayam, Vellore 632002. Vellore. Tamil Nadu. India. Phone: 04162284520. Email: prathap@cmcvellore.ac.in
Notes

CGI‐I: Clinical Global Impression Improvement
 ICD‐10: International Classification of Diseases, Tenth Revision