Study on rapid tranquilization: comparison of intramuscular olanzapine and intramuscular haloperidol

Not Applicable

Conditions: Psychiatric conditions

Registration Number: SLCTR/2011/013

Lead Sponsor: Dr Varuni de Silva,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 134

Inclusion Criteria

1. Age 18-65 years
2. Patients admitted with acute agitation or already hospitalized and become agitated with a total score of Positive and Negative Symptoms Scale-Excited Component (PANSS-EC) >= 14 or at least one item with a score of >= 4 (If this requirement is not met at baseline and rapid tranquilization has not been given the patient could be re-evaluated in the subsequent 24 hours)
3. Clear indication of intramuscular route of administration according to the attending doctor because of agitation, aggression, or violent behaviour
4. Presence of good physical health confirmed by medical history and physical examination

Exclusion Criteria

1. Agitation primarily due to acute intoxication
2. History of drug or alcohol dependence in the previous 8 weeks
3. Use of benzodiazepines / other hypnotics/ oral or intramuscular antipsychotic in the 4 hours before study intervention
4. Use of depot antipsychotic within one dose interval before study intervention
5. Clinically significant acute or chronic pulmonary disease/ clinically significant hepatic, renal, gastroenterological, cardiovascular, neurological or hematological disease
6. Pregnant or lactating females

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive and Negative Symptoms Scale – Excited Component (PANSS–EC) [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention]<br>Clinical Global Impression Scale (CGI) [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention]<br>Agitation Calmness Evaluation Scale (ACES) [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention ]<br>Overt Aggression scale (OAS) [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention ]<br>

Secondary Outcome Measures

Name	Time	Method
Proportion of patients requiring medical attention due to continued agitation<br> [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention]<br>Proportion of patients requiring physical restraining [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention]<br>Proportion of that needed additional medication [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention]<br>Extrapyramidal side effects with Simpson Angus Extrapyramidal symptom scale and Barnes akathisia scale [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention]<br>Vital signs (heart rate, respiratory rate,systolic and diastolic blood pressure) [At baseline, 15 minutes, 30 minutes, 60 minutes and 120 minutes after intervention]<br>