Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-31 @ 2:06 AM
Study NCT ID:
NCT01485692
Status:
COMPLETED
Last Update Posted:
2011-12-05
First Post:
2011-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Four Interventions in the Management of Psychomotor Agitation, Safety and Efficacy Evaluation
Sponsor:
University of Sao Paulo
Organization:
Study Overview
Official Title:
Safety and Efficacy of Four Intramuscular Interventions for the Management of Acute Psychomotor Agitation
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the efficacy and safety of four options of medications in the management of acute psychomotor agitation,or violence and aggression situations in health services. All of the treatment options are already approved and currently used for this purpose. The options are: haloperidol plus midazolam, haloperidol plus promethazine, olanzapine and ziprasidone. The investigators hypothesized that all treatment options are effective in the treatment of acute agitation, but the combination haloperidol plus promethazine could elicit more adverse affects than the others.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: