Trial Outcomes & Findings for Treating Acutely Agitated Patients With Asenapine Sublingual Tablets (NCT NCT01400113)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

120 participants

Primary outcome timeframe

Change in PANSS-EC score from baseline to 2 hours post drug/placebo administration.

Results posted on

2016-05-16

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Asenapine 60 patients were randomized to this group	Placebo 60 patients were randomized to this group
Overall Study STARTED	60	60
Overall Study COMPLETED	59	59
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Asenapine 60 patients were randomized to this group	Placebo 60 patients were randomized to this group
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Treating Acutely Agitated Patients With Asenapine Sublingual Tablets

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asenapine n=60 Participants 60 patients were randomized to this group	Placebo n=60 Participants 60 patients were randomized to this group	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=39 Participants	60 Participants n=41 Participants	120 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Continuous	36.3 years STANDARD_DEVIATION 11.1 • n=39 Participants	36.4 years STANDARD_DEVIATION 12.4 • n=41 Participants	36.4 years STANDARD_DEVIATION 11.75 • n=35 Participants
Sex: Female, Male Female	17 Participants n=39 Participants	24 Participants n=41 Participants	41 Participants n=35 Participants
Sex: Female, Male Male	43 Participants n=39 Participants	36 Participants n=41 Participants	79 Participants n=35 Participants
Region of Enrollment United States	60 participants n=39 Participants	60 participants n=41 Participants	120 participants n=35 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Asenapine n=59 Participants 60 patients were randomized to this group	Placebo n=59 Participants 60 patients were randomized to this group
Positive and Negative Syndrome Scale - Excited Component	7.86 PANSS SCORE Interval 2.06 to 13.66	14.93 PANSS SCORE Interval 7.69 to 22.17

SECONDARY outcome

Timeframe: 2 hours

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

Outcome measures

Outcome data not reported

Adverse Events

Asenapine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Pratts, MD

St. Joseph's Hospital Health Center

Phone: 315-726-8610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place