Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06093451
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-10-05
Brief Title:
Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
An Open-Label Randomized Active Controlled Inpatient Trial Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder
Status:
RECRUITING
Status Verified Date:
2023-10
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:
An open-label randomized active control inpatient trial to evaluate the efficacy and tolerability of sublingual dexmedetomidine for the treatment of agitation in inpatients with schizophrenia or bipolar disorder as measured by the Positive and Negative Syndrome Scale - Excited Component PANSS-EC and Agitation-Calmness Evaluation Scale ACES Lorazepam will serve as the active control
Detailed Description:
This is an open-label randomized control trial where patients N32 with schizophrenia or bipolar disorder are randomized to receive either sublingual dexmedetomidine or oral lorazepam monotherapy for the treatment of episodic agitation For moderate agitation PANSS-EC score 14 and 20 patients will receive either sublingual dexmedetomidine 120mcg or oral lorazepam 2mg For severe agitation PANSS-EC 20 patients will receive either sublingual dexmedetomidine 180mcg or oral lorazepam 2mg The PANSS-EC and ACES will be evaluated at baseline and after 15 30 60 and 120 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None