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Rapid Tranquillization Trial: TREC-India II (TRECIndia-II)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00455234
First Posted: April 3, 2007
Last Update Posted: April 3, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Christian Medical College, Vellore, India
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, India
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00455234     History of Changes
Other Study ID Numbers: 22F484
First Submitted: March 30, 2007
First Posted: April 3, 2007
Last Update Posted: April 3, 2007
Last Verified: March 2007

Keywords provided by Christian Medical College, Vellore, India:
Aggression
Violent behaviour in people with psychotic illness

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Aggression
Schizophrenia Spectrum and Other Psychotic Disorders
Behavioral Symptoms
Haloperidol
Diphenhydramine
Haloperidol decanoate
Promethazine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Allergic Agents
Anesthetics, Local