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

This study has been completed.
Sponsor:
Information provided by:
Christian Medical College, Vellore, India
ClinicalTrials.gov Identifier:
NCT00455234
First received: March 30, 2007
Last updated: April 2, 2007
Last verified: March 2007
  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
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, India
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 23, 2014