A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Agitation |
| Intervention | Drug: Quetiapine Drug: Cocktail (Haloperidol, Lorazepam, Cogentin) |
| Phase | Phase 4 |
| Sponsor | University of Southern California |
| Responsible Party | University of Southern California |
| ClinicalTrials.gov Identifier | NCT00457366 |
| First Received | April 4, 2007 |
| Last Updated | January 29, 2014 |
| Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 4, 2007 |
|---|---|
| Last Updated Date | January 29, 2014 |
| Start Date | May 2006 |
| Estimated Primary Completion Date | May 2009 |
| Current Primary Outcome Measures | Decrease in the PANSS-EC two hours after administration of the medication. [Time Frame: Two hours] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room |
|---|---|
| Official Title | A Comparison Study of the Efficacy of a Rapid Titration of Quetiapine and Haloperidol in Agitated Adults in an Emergency Setting. |
| 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. 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Agitation |
| Intervention | Drug: Quetiapine Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary upto a maximum dose of Quetiapine 600mg PO QD Drug: Cocktail (Haloperidol, Lorazepam, Cogentin) Haloperidol 5 mg im, Lorazepam 2 mg im, Cogentin 2 mg im; repeated at 2 hours as deemed clinically necessary |
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 72 |
| Estimated Completion Date | May 2009 |
| Estimated Primary Completion Date | August 2008 |
| Eligibility Criteria | 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00457366 |
|---|---|
| Other Study ID Numbers | HS-05-00331 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | University of Southern California |
| Study Sponsor | University of Southern California |
| Collaborators | AstraZeneca |
| Investigators | Principal Investigator: George M Simpson, MD USC+LAC Medical Center |
| Verification Date | January 2014 |
Locations[ + expand ][ + ]
| Los Angeles County Hospital | Los Angeles, California, United States, 90033 |
|---|