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

NCT00457366 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: HS-05-00331
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Agitation

Outcome Measures

Primary Outcomes (1)

• Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication.

  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).

  Two hours

Study Arms (4)

Quetiapine

ACTIVE COMPARATOR

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

Drug: Quetiapine

Haloperidol

ACTIVE COMPARATOR

"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

Lorazepam

ACTIVE COMPARATOR

"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

Cogentin

ACTIVE COMPARATOR

"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

Interventions

Quetiapine DRUG

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

Also known as: no other name

Quetiapine

Haloperidol DRUG

given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary

Also known as: no other names

Haloperidol

Lorazepam DRUG

given in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary.

Also known as: no other name

Lorazepam

Cogentin DRUG

given in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary.

Also known as: no other name

Cogentin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• English or Spanish speaking patients
• Provision of written informed consent-English and Spanish
• Males and females age 18 to 60 years. Females who are pregnant by inspection should not be included.
• 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.
• Ability, in the treating physician's opinion, to co-operate with taking oral medication

You may not qualify if:

• Pregnant females who will thus receive routine care in the treating physician's opinion
• Unstable medical illness
• Withdrawal stage from any illicit drugs
• Psychosis that prohibits participation in trial
• Females of childbearing age where pregnancy cannot be confirmed or denied by screening
• Patients who required continued intervention or prolonged restraint

Sponsors & Collaborators

• University of Southern California: lead
• AstraZeneca: collaborator

Study Sites (1)

Los Angeles County Hospital

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Quetiapine Fumarate; Haloperidol; Lorazepam; Benztropine

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Butyrophenones; Ketones; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Dr George Simpson
• Organization: USC

gsimpson@usc.edu

7604687106

Study Officials

• George M Simpson, MD

  USC+LAC Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 6, 2007
• Study Start: May 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: May 1, 2009
• Last Updated: July 26, 2019
• Results First Posted: July 5, 2019

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)