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| Sponsored by: |
Christian Medical College, Vellore, India |
|---|---|
| Information provided by: | Christian Medical College, Vellore, India |
| ClinicalTrials.gov Identifier: | NCT00455234 |
Purpose
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 agitated or aggressive behavior will be randomized to receive either Injection Olanzepine I.M. or Injection Haloperidol 10mg + Injection Promethazine 50 mg in this parallel group, block randomized, centrally-randomzed, allocation-concealed, assessor-blinded pragmatic clinical trial.
The main outcome measure that the two treatments would be compared on would be the clinical state of the patient 4 hours after intervention, but the rate of tranquillization, degree of sedation, proportions tranquil and / or asleep at 15, 30, 60 and 240 minutes, need for additional medication, use of physical restraints, doctors called back, numbers absconding and adverse effects at each of these time points would also be compared. Compliance with oral medication and adverse effects at the end of 2 weeks would also be compared.
| Condition | Intervention | Phase |
|---|---|---|
|
Psychotic Disorders Aggression |
Drug: Intramuscular Olanzepine 10 mg Drug: Intramuscular Haloperidol 5-10 mg + Promethazine 25-50 mg |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Rapid Tranquilization of Violent or Agitated People in Psychiatric Emergency Settings- A Pragmatic Randomized Controlled Trial of Intramuscular Olanzepine Vs. Intramuscular Haloperidol + Promethazine. |
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2005 |
| Study Completion Date: | July 2006 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| India, Tamil Nadu | |
| Department of Psychiatry, Christian Medical College | |
| Vellore, Tamil Nadu, India, 632002 | |
| Study Director: | Prathap Tharyan | Christian Medical College, Vellore |
More Information
| Study ID Numbers: | 22F484 |
| Study First Received: | March 30, 2007 |
| Last Updated: | April 2, 2007 |
| ClinicalTrials.gov Identifier: | NCT00455234 History of Changes |
| Health Authority: | India: Institutional Review Board |
|
Aggression Violent behaviour in people with psychotic illness |
|
Neurotransmitter Agents Psychotropic Drugs Antiemetics Anesthetics Psychomotor Agitation Haloperidol Schizophrenia Dopamine Promethazine Mental Disorders Hypnotics and Sedatives Antipruritics Psychotic Disorders Aggression Schizophrenia and Disorders with Psychotic Features |
Tranquilizing Agents Central Nervous System Depressants Anti-Allergic Agents Antipsychotic Agents Anesthetics, Local Behavioral Symptoms Histamine Haloperidol decanoate Histamine Antagonists Emergencies Histamine H1 Antagonists Histamine phosphate Dopamine Agents Peripheral Nervous System Agents Diphenhydramine |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Anesthetics Antiemetics Haloperidol Promethazine Sensory System Agents Mental Disorders Therapeutic Uses Hypnotics and Sedatives Antipruritics Psychotic Disorders |
Aggression Dermatologic Agents Schizophrenia and Disorders with Psychotic Features Tranquilizing Agents Gastrointestinal Agents Central Nervous System Depressants Histamine Agents Dopamine Antagonists Anti-Allergic Agents Antipsychotic Agents Anesthetics, Local Pharmacologic Actions Behavioral Symptoms Haloperidol decanoate Histamine Antagonists |
