A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room

Sponsor
University of Southern California (Other)
Overall Status
Completed
CT.gov ID
NCT00457366
Collaborator
AstraZeneca (Industry)
72
Enrollment
1
Location
4
Arms
36
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. However, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients as well as more likely to cause EPS (extrapyramidal symptoms). Of late in our emergency room, we started using high dose Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising results.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

Detailed Description

In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. However, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients as well as more likely to cause EPS (extrapyramidal symptoms). Of late in our emergency room, we started using high dose Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising results.

This study is designed to compare the efficacy and safety of Quetiapine with the routine "cocktail for treatment of agitation.

The primary purpose of this study is to determine the efficacy and safety of Quetiapine by using high dose Quetiapine (300 mg) PO to treat agitated patients in the psychiatric emergency room.

The secondary purpose is to test the immediate effect on agitation caused by illicit drug abuse or the alcohol abuse.

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Comparison Study of the Efficacy of a Rapid Titration of Quetiapine and Haloperidol in Agitated Adults in an Emergency Setting.
Study Start Date :
May 1, 2006
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
May 1, 2009

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Quetiapine

Quetiapine is being used in an ER setting on agitated patients, being administered orally.

Drug: Quetiapine
Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary up to a maximum dose of Quetiapine 600mg PO QD
Other Names:
  • no other name
  • Active Comparator: Haloperidol

    "Haloperidol" is being used in an ER setting on agitated patients, administered IM. This is being used in combination with lorazepam and cogentin. We are comparing the use of this "cocktail" to quetiapine alone.

    Drug: Haloperidol
    given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary
    Other Names:
  • no other names
  • Active Comparator: Lorazepam

    "Lorazepam" is being used in an ER setting on agitated patients, administered IM.This is being used in combination with haloperidol, and cogentin. We are comparing the use of this "cocktail" to quetiapine alone.

    Drug: Lorazepam
    given in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary.
    Other Names:
  • no other name
  • Active Comparator: Cogentin

    "Cogentin" is being used in an ER setting on agitated patients, administered IM. This is being used in combination with haloperidol, and lorazepam. We are comparing the use of this "cocktail" to quetiapine alone.

    Drug: Cogentin
    given in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary.
    Other Names:
  • no other name
  • Outcome Measures

    Primary Outcome Measures

    1. Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication. [Two hours]

      The PANSS-EC is the Positive and Negative Syndrome Score - Excited Component, which includes 5 items (excitement, hostility, tension, uncooperative, poor impulse control), which are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients with different psychiatric pathologies (Montoya, A; Villadares, A; Lizan, L, et al., 2011).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. English or Spanish speaking patients

    2. Provision of written informed consent-English and Spanish

    3. Males and females age 18 to 60 years. Females who are pregnant by inspection should not be included.

    4. Provision at diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV) criteria for Axis I documented who present in an agitated state. PANSS-EC score should be >15.

    5. Ability, in the treating physician's opinion, to co-operate with taking oral medication

    Exclusion Criteria:
    1. Pregnant females who will thus receive routine care in the treating physician's opinion

    2. Unstable medical illness

    3. Withdrawal stage from any illicit drugs

    4. Psychosis that prohibits participation in trial

    5. Females of childbearing age where pregnancy cannot be confirmed or denied by screening

    6. Patients who required continued intervention or prolonged restraint

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Los Angeles County HospitalLos AngelesCaliforniaUnited States90033

    Sponsors and Collaborators

    • University of Southern California
    • AstraZeneca

    Investigators

    • Principal Investigator: George M Simpson, MD, USC+LAC Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Southern California
    ClinicalTrials.gov Identifier:
    NCT00457366
    Other Study ID Numbers:
    • HS-05-00331
    First Posted:
    Apr 6, 2007
    Last Update Posted:
    Jul 26, 2019
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleQuetiapine"Cocktail" Consisting of Haloperidol, Lorazepam, Cogentin
    Arm/Group DescriptionQuetiapine is being compared to a "cocktail" consisting of haloperidol, lorazepam, and cogentin to see which works best in agitated patients that are being brought into the ER.This "cocktail" consisting of haloperidol, lorazepam, and cogentin is being compared to quetiapiene to see which works best in agitated patients that are being brought into the ER.
    Period Title: Overall Study
    STARTED4032
    COMPLETED4032
    NOT COMPLETED00

    Baseline Characteristics

    Arm/Group TitleQuetiapineCocktailTotal
    Arm/Group DescriptionQuetiapine Quetiapine: Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary upto a maximum dose of Quetiapine 600mg PO QDCocktail (Haloperidol, Lorazepam, Cogentin) Cocktail (Haloperidol, Lorazepam, Cogentin): Haloperidol 5 mg im, Lorazepam 2 mg im, Cogentin 2 mg im; repeated at 2 hours as deemed clinically necessaryTotal of all reporting groups
    Overall Participants383472
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    38
    100%
    34
    100%
    72
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    36.1
    35.8
    36.0
    Sex: Female, Male (Count of Participants)
    Female
    9
    23.7%
    6
    17.6%
    15
    20.8%
    Male
    29
    76.3%
    28
    82.4%
    57
    79.2%
    Region of Enrollment (participants) [Number]
    United States
    38
    100%
    34
    100%
    72
    100%

    Outcome Measures

    1. Primary Outcome
    TitleChange in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication.
    DescriptionThe PANSS-EC is the Positive and Negative Syndrome Score - Excited Component, which includes 5 items (excitement, hostility, tension, uncooperative, poor impulse control), which are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients with different psychiatric pathologies (Montoya, A; Villadares, A; Lizan, L, et al., 2011).
    Time FrameTwo hours

    Outcome Measure Data

    Analysis Population Description
    34 patients received the Cocktail, but 4 of these were excluded from the analysis because they had only demographic data and no clinical outcome data. A total of 38 patients received Quetiapine; all were included in the analysis.
    Arm/Group TitleCocktailQuetiapine
    Arm/Group DescriptionCocktail (Haloperidol, Lorazepam, Cogentin): Haloperidol 5 mg im, Lorazepam 2 mg im, Cogentin 2 mg im; repeated at 2 hours as deemed clinically necessary.Quetiapine 300 mg PO
    Measure Participants3038
    Least Squares Mean (Standard Error) [score on a scale]
    -11.0
    (0.82)
    -11.5
    (0.69)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Cocktail, Quetiapine
    Comments
    Type of Statistical Test Other
    Comments We used an analysis of covariance (ANCOVA) with baseline as the covariate to analyze the PANSS-EC at hour 2.
    Statistical Test of Hypothesisp-Value>0.05
    Comments
    MethodANCOVA
    Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group TitleQuetiapineCocktail
    Arm/Group DescriptionQuetiapine Quetiapine: Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary upto a maximum dose of Quetiapine 600mg PO QDCocktail (Haloperidol, Lorazepam, Cogentin) Cocktail (Haloperidol, Lorazepam, Cogentin): Haloperidol 5 mg im, Lorazepam 2 mg im, Cogentin 2 mg im; repeated at 2 hours as deemed clinically necessary
    All Cause Mortality
    QuetiapineCocktail
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN)
    Serious Adverse Events
    QuetiapineCocktail
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/40 (0%) 0/32 (0%)
    Other (Not Including Serious) Adverse Events
    QuetiapineCocktail
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/40 (0%) 0/32 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleDr George Simpson
    OrganizationUSC
    Phone7604687106
    Emailgsimpson@usc.edu
    Responsible Party:
    University of Southern California
    ClinicalTrials.gov Identifier:
    NCT00457366
    Other Study ID Numbers:
    • HS-05-00331
    First Posted:
    Apr 6, 2007
    Last Update Posted:
    Jul 26, 2019
    Last Verified:
    Apr 1, 2017