A comparative study of the effects of injection zuclopenthixol acetate versus injection haloperidol plus promethazine in psychiatric emergencies.

Rapid tranquillization of violent or agitated patients in a psychiatric emergency setting: Pragmatic, randomized, allocation concealed, participant and assessor blinded trial of intramuscular zuclopenthixol acetate versus intramuscular haloperidol plus promethazine. - TREC- India III

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/07/004712

Enrollment

350

Registered

2014-07-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Schizophrenia, Depression with psychosis, Mania

Interventions

Intervention1: Zuclopenthixol acetate: Intramuscular injection as a single dose Dose: 100 mg (range 50-150 mg) Control Intervention1: Haloperidol plus Promethazine: Intramuscular injection, single dos

Eligibility

Inclusion criteria

Inclusion criteria: Adults ( >18 years) with an ICD-10 diagnoses of F10, F20-29, F30-39 and F60-62 presenting to the emergency services of the Department of Psychiatry with aggression/violent behaviours or agitation requiring rapid tranquilization as judged by the attending physician, and requiring to be admitted in the emergency room for observation

Exclusion criteria

Exclusion criteria: Participants without responsible relatives to give consent; If one of the agents represents additional risk for the patient, as determined by the treating clinician; Level of disturbance rated on CGI-Severity scale of only mildly ill (as assessed by PI).

Design outcomes

Primary

Measure	Time frame
1. The proportion of participants in each intervention arm considered â??tranquilâ?? or â??asleepâ?? at: a. 15 minutes, and at b. 240 minutes (four hours) 2. Proportions in each intervention arm requiring additional injections over the first four hours; in first 24 hours; and over 48 hours due to violent or agitated behaviour Timepoint: a. 15 minutes b. 240 minutes (four hours) c. 24 hours d. 48 hours	—

Measure

Time frame

1. The proportion of participants in each intervention arm considered â??tranquilâ?? or â??asleepâ?? at: a. 15 minutes, and at b. 240 minutes (four hours) 2. Proportions in each intervention arm requiring additional injections over the first four hours; in first 24 hours; and over 48 hours due to violent or agitated behaviour Timepoint: a. 15 minutes b. 240 minutes (four hours) c. 24 hours d. 48 hours

—

Secondary

Measure	Time frame
1. Tranquil or asleep 2. In restraints 3. â??Much improvedâ?? or â??very much improvedâ?? (CGI-Improvement). 4. Doctors called back. 5. Additional oral interventions 6. Absconding 7. Dystonic reactions and extrapyramidal symptoms 8. Other adverse events over 48 hours. 9. Direct costs of interventions 10. Aggressive/violent behaviour over two weeks ii. Adherence to prescribed medication at two weeks (or next earliest visit).Timepoint: 30 minutes, 60 minutes, 120 minutes, 24 hours, 48 hours, 2 weeks	—

Measure

Time frame

1. Tranquil or asleep 2. In restraints 3. â??Much improvedâ?? or â??very much improvedâ?? (CGI-Improvement). 4. Doctors called back. 5. Additional oral interventions 6. Absconding 7. Dystonic reactions and extrapyramidal symptoms 8. Other adverse events over 48 hours. 9. Direct costs of interventions 10. Aggressive/violent behaviour over two weeks ii. Adherence to prescribed medication at two weeks (or next earliest visit).Timepoint: 30 minutes, 60 minutes, 120 minutes, 24 hours, 48 hours, 2 weeks

—

Countries

India

Contacts

Public ContactDr Starlin Vijay Mythri

Christian Medical College

prathap@cmcvellore.ac.in04162284520

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026