Treating Acutely Agitated Patients With Asenapine Sublingual Tablets

• Sponsor: Unity Health Toronto (Other)
• Overall Status: Completed
• CT.gov ID: NCT01400113
• Collaborator: Schering-Plough (Industry)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 15

Study Details

Study Description

Brief Summary

Our proposal is to administer asenapine to patients who are clinically agitated and in need of immediate intervention. At present there are no controlled studies that we know of that explores the use of asenapine for this purpose. Establishing the utility of asenapine for this common clinical problem will support its use as an additional treatment option in acutely agitated patients.

Condition or Disease	Intervention/Treatment	Phase
Agitation	Drug: Asenapine; Drug: Placebo	Phase 4

Detailed Description

A psychiatrist (blinded) will assess the patient for agitation and their capacity to consent. Patients will be informed about the study and asked to complete informed consent prior to being included in the study. Patients who decline will not be included. A nurse (blinded) will administer either 10mg asenapine or placebo sublingually in a randomized fashion. Efficacy in reducing acute agitation will be evaluated using the PANSS-EC. A trained rater (blinded) will rate patients at baseline and at 15, 30, 60, 90 and 120 minutes (or endpoint) after medication administration. Efficacy in reducing acute agitation will also be evaluated using the Clinical Global Impression Scale (CGI). A trained rater (blinded) will rate patients at baseline CGI-Severity and CGI-Change at 60 and 120 minutes (or endpoint) after medication administration. The need for additional medications, interventions or physical restraints will be recorded and constitute the endpoint for that patient. Demographics, diagnoses, blood alcohol level, urine toxicology, and urine pregnancy will be collected.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Treating Acutely Agitated Patients With Asenapine Sublingual Tablets: A Single-Dose, Randomized, Double-Blind Placebo Controlled Trial
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Asenapine This group received 10mg asenapine sl x 1 dose	Drug: Asenapine; Asenapine Sublingual Tablet 10mg, single-dose; Other Names: Saphris
Placebo Comparator: Placebo This group received placebo sl x 1 dose	Drug: Placebo; Placebo Sublingual Tablet, single-dose; Other Names: Sugar Pill

Outcome Measures

Primary Outcome Measures

1. Positive and Negative Syndrome Scale - Excited Component [Change in PANSS-EC score from baseline to 2 hours post drug/placebo administration.]

   The primary outcome measure is change in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) from baseline to 2 hours after medication administration. The PANSS-EC consists of 5 items: excitement, tension, hostility, uncooperativeness, and poor impulse control. The 5 items from the PANSS-EC 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.

Secondary Outcome Measures

1. Clinical Global Impression Scale [2 hours]

   Secondary outcome measures will include the Clinical Global Impression -Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients will be between the ages of 18 and 65

• Be acutely agitated as determined by a total score of ≧ 14 on the PANSS-EC and at least one individual item score of ≧ 4

• Patients must have the capacity to provide informed consent, and such consent will be obtained prior to participation

Exclusion Criteria:

• Patient is knowingly pregnant

• Patient is less than 18 or greater than 65 years old

• Patient had a past adverse or allergic response to Asenapine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Hospital Health Center-Comprehensive Psychiatric Emergency Program (CPEP)	Syracuse	New York	United States	13203

Sponsors and Collaborators

• Unity Health Toronto
• Schering-Plough

Investigators

• Principal Investigator: Michael J Pratts, MD, St. Joseph's Hospital Health Center - CPEP
• Principal Investigator: Laura Leso, MD, St. Joseph's Hospital Health Center - CPEP
• Principal Investigator: David Frey, MD, St. Joseph's Hospital Health Center - CPEP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael J. Pratts, M.D., Psychiatrist, Unity Health Toronto
• ClinicalTrials.gov Identifier: NCT01400113
• Other Study ID Numbers: P00184
• First Posted: Jul 22, 2011
• Last Update Posted: May 16, 2016
• Last Verified: Apr 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Michael J. Pratts, M.D., Psychiatrist, Unity Health Toronto: Acute Agitation; schizophrenia; bipolar; psychosis; panss-ec
• Additional relevant MeSH terms: Psychomotor Agitation; Asenapine

Study Results

Participant Flow

Recruitment Details	Between 4/23/12 and 12/11/12, adult, non-pregnant patients in a Psychiatric Emergency Room were assessed by a psychiatrist for agitation. Those patients who were willing to participate and signed an informed consent were enrolled.

Arm/Group Title	Asenapine	Placebo
Arm/Group Description	60 patients were randomized to this group	60 patients were randomized to this group
Period Title: Overall Study
STARTED	60	60
COMPLETED	59	59
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Asenapine	Placebo	Total
Arm/Group Description	60 patients were randomized to this group	60 patients were randomized to this group	Total of all reporting groups
Overall Participants	60	60	120
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	60 100%	60 100%	120 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.3 (11.1)	36.4 (12.4)	36.4 (11.75)
Sex: Female, Male (Count of Participants)
Female	17 28.3%	24 40%	41 34.2%
Male	43 71.7%	36 60%	79 65.8%
Region of Enrollment (participants) [Number]
United States	60 100%	60 100%	120 100%

Outcome Measures

1. Primary Outcome

Title	Positive and Negative Syndrome Scale - Excited Component
Description	The primary outcome measure is change in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) from baseline to 2 hours after medication administration. The PANSS-EC consists of 5 items: excitement, tension, hostility, uncooperativeness, and poor impulse control. The 5 items from the PANSS-EC 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.
Time Frame	Change in PANSS-EC score from baseline to 2 hours post drug/placebo administration.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Asenapine	Placebo
Arm/Group Description	60 patients were randomized to this group	60 patients were randomized to this group
Measure Participants	59	59
Mean (95% Confidence Interval) [PANSS SCORE]	7.86	14.93

2. Secondary Outcome

Title	Clinical Global Impression Scale
Description	Secondary outcome measures will include the Clinical Global Impression -Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales.
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Asenapine		Placebo
Arm/Group Description	Asenapine: Asenapine Sublingual Tablet 10mg, single-dose		Placebo: Placebo Sublingual Tablet, single-dose
All Cause Mortality
	Asenapine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Asenapine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Asenapine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)

Limitations/Caveats

The short observation period of 2 hours. Dependence on spontaneous self reporting of adverse effects. Specific inquiry was not made regarding adverse events.

More Information

Certain Agreements

All Principal Investigators ARE 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.