A comparative study of the effects of injection zuclopenthixol acetate versus injection haloperidol plus promethazine in psychiatric emergencies.
Phase 3
- Conditions
- Health Condition 1: null- Schizophrenia, Depression with psychosis, Mania
- Registration Number
- CTRI/2014/07/004712
- Lead Sponsor
- Christian Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 350
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
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.The proportion of participants in each intervention arm considered â??tranquilâ?? or â??asleepâ?? at: <br/ ><br>a.15 minutes, and at <br/ ><br>b.240 minutes (four hours) <br/ ><br>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 <br/ ><br>Timepoint: a.15 minutes <br/ ><br>b.240 minutes (four hours) <br/ ><br>c. 24 hours <br/ ><br>d. 48 hours <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Tranquil or asleep <br/ ><br>2.In restraints <br/ ><br>3.â??Much improvedâ?? or â??very much improvedâ?? (CGI-Improvement). <br/ ><br>4.Doctors called back. <br/ ><br>5.Additional oral interventions <br/ ><br>6.Absconding <br/ ><br>7.Dystonic reactions and extrapyramidal symptoms <br/ ><br>8.Other adverse events over 48 hours. <br/ ><br>9.Direct costs of interventions <br/ ><br>10. Aggressive/violent behaviour over two weeks <br/ ><br>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