Rapid Tranquillization Trial: TREC-India II - Full Text View

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Mental Disorders Psychotic Disorders

Drug Information available for: Haloperidol Promethazine hydrochloride Diphenhydramine Promethazine Haloperidol decanoate Haloperidol lactate Diphenhydramine citrate Diphenhydramine hydrochloride

U.S. FDA Resources

Further study details as provided by Christian Medical College, Vellore, India:

Primary Outcome Measures:

Number of participants tranquil or alseep at four hours after the intevention

Secondary Outcome Measures:

Number of participants tranquil or asleep at 15 minutes, 30 munites, 60 minutes, 120 minutes, 240 minutes after the intervention
Number of participants in restraints at 15 minutes, 30 munites, 60 minutes, 120 minutes, 240 minutes after the intervention
Number of participants who had absconded at 15 minutes, 30 munites, 60 minutes, 120 minutes, 240 minutes after the intervention
Number of participants who recived additional medication at 15 minutes, 30 munites, 60 minutes, 120 minutes, 240 minutes after the intervention
Number of participants for whom the doctor was called back at 15 minutes, 30 munites, 60 minutes, 120 minutes, 240 minutes after the intervention
Mean time till tranquillization
Mean time till asleep
Proportions improved on Clinical Global Impression scale at ech time pointof follow up
Mean change on CGI scores at each time pint of follow up
Adverse effects reported/observed
Scores on Simpson-Angus extrapyramidal rating scale
Scores on Barnes Akathisia Rating Scale

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

Criteria

Inclusion Criteria:

Person with a major mental disorder needs acute intramuscular sedation because of disturbed and dangerous behavior as decided by the attending physician.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455234

Locations

India
Department of Psychiatry, Christian Medical College
Vellore, Tamil Nadu, India, 632002

Sponsors and Collaborators

Christian Medical College, Vellore, India

Investigators

Study Director:

Prathap Tharyan

Christian Medical College, Vellore

More Information

Publications:

Alexander J, Tharyan P, Adams C, John T, Mol C, Philip J. Rapid tranquillisation of violent or agitated patients in a psychiatric emergency setting. Pragmatic randomised trial of intramuscular lorazepam v. haloperidol plus promethazine. Br J Psychiatry. 2004 Jul;185:63-9.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Raveendran NS, Tharyan P, Alexander J, Adams CE; TREC-India II Collaborative Group. Rapid tranquillisation in psychiatric emergency settings in India: pragmatic randomised controlled trial of intramuscular olanzapine versus intramuscular haloperidol plus promethazine. BMJ. 2007 Oct 27;335(7625):865. Epub 2007 Oct 22.

ClinicalTrials.gov Identifier:	NCT00455234 History of Changes
Other Study ID Numbers:	22F484
Study First Received:	March 30, 2007
Last Updated:	April 2, 2007
Health Authority:	India: Institutional Review Board

Keywords provided by Christian Medical College, Vellore, India:

Aggression
Violent behaviour in people with psychotic illness

Additional relevant MeSH terms:

Aggression
Psychotic Disorders
Mental Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features
Promethazine
Diphenhydramine
Haloperidol
Haloperidol decanoate
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists

Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anesthetics, Local
Anesthetics
Sensory System Agents

ClinicalTrials.gov processed this record on February 09, 2012