Status:
COMPLETED
Rapid Tranquillization Trial: TREC-India II
Lead Sponsor:
Christian Medical College, Vellore, India
Conditions:
Psychotic Disorders
Aggression
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Three hundred consecutive adult patients presenting to the emergency services of the department of psychiatry and who are diagnosed by the treating doctor to be needing tranquillization to control agi...
Detailed Description
Participants: Consecutive adult psychiatric patients presenting to the department of psychiatry as outpatients, or those who are admitted, who have violent, aggressive or agitated behavior. Inclusio...
Eligibility Criteria
Inclusion
- Person with a major mental disorder needs acute intramuscular sedation because of disturbed and dangerous behavior as decided by the attending physician.
Exclusion
- The clinician believes that one of the two treatments represents an additional risk for the patient and/or
- Patients who lack capacity to give informed consent and who do not have a relative to obtain consent.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00455234
Start Date
September 1 2005
End Date
July 1 2006
Last Update
April 3 2007
Active Locations (1)
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1
Department of Psychiatry, Christian Medical College
Vellore, Tamil Nadu, India, 632002