AgitationPhase 4NCT01400113
Treating Acutely Agitated Patients With Asenapine Sublingual Tablets
A Phase 4 study testing Asenapine in people with Agitation, run by Unity Health Toronto at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Agitation
- What is being tested?
- Asenapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph's Hospital Health Center-Comprehensive Psychiatric Emergency Program (CPEP)
Syracuse, New York, 13203
About this study
Official title: Treating Acutely Agitated Patients With Asenapine Sublingual Tablets: A Single-Dose, Randomized, Double-Blind Placebo Controlled Trial
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.
Read the 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.
- Conditions
- Agitation
- Being tested
- Asenapine, Placebo
- Keywords
- Acute Agitation, schizophrenia, bipolar, psychosis, panss-ec
- Medical subject headings
- Psychomotor Agitation, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsenapineDrug
Also called Saphris
Asenapine Sublingual Tablet 10mg, single-dose
PlaceboDrug
Also called Sugar Pill
Placebo Sublingual Tablet, single-dose
| Study group | Role | What they receive |
|---|---|---|
| Asenapine | Experimental | This group received 10mg asenapine sl x 1 dose Receives: Drug: Asenapine |
| Placebo | Placebo comparator | This group received placebo sl x 1 dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale - Excited Component
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.
Measured: Change in PANSS-EC score from baseline to 2 hours post drug/placebo administration.
Secondary outcomes (1)
Clinical Global Impression Scale
Secondary outcome measures will include the Clinical Global Impression -Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgitationStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Principal investigator, Michael J. Pratts, M.D., Unity Health Toronto
- Investigators
- Michael J Pratts, MD, Principal investigator, St. Joseph's Hospital Health Center - CPEPLaura Leso, MD, Principal investigator, St. Joseph's Hospital Health Center - CPEPDavid Frey, MD, Principal investigator, St. Joseph's Hospital Health Center - CPEP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400113
- Sponsor's protocol ID
- P00184
- Status last verified
- Apr 2016
- First submitted
- 18 Jul 2011
- Last updated
- 16 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All data available upon request.
Publications
Pratts M, Citrome L, Grant W, Leso L, Opler LA. A single-dose, randomized, double-blind, placebo-controlled trial of sublingual asenapine for acute agitation. Acta Psychiatr Scand. 2014 Jul;130(1):61-8. doi: 10.1111/acps.12262. Epub 2014 Mar 10.
PubMed 24606117
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Acutely Agitated Patients With Asenapine Sublingual Tablets: A Single-Dose, Randomized, Double-Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT01400113
- Acronym / sponsor ID
- P00184
- Conditions
- Agitation
- Keywords
- Acute Agitation, schizophrenia, bipolar, psychosis, panss-ec
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Posted 16 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asenapine | Experimental | Drug: AsenapineThis group received 10mg asenapine sl x 1 dose |
| Placebo | Placebo comparator | Drug: PlaceboThis group received placebo sl x 1 dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AsenapineAlso: SaphrisAsenapine Sublingual Tablet 10mg, single-dose | Drug | Asenapine |
| PlaceboAlso: Sugar PillPlacebo Sublingual Tablet, single-dose | Drug | Placebo |
Primary outcome
Positive and Negative Syndrome Scale - Excited Component
Time frame: 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.
1 secondary outcome
Clinical Global Impression Scale
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24606117Pratts M, Citrome L, Grant W, Leso L, Opler LA. A single-dose, randomized, double-blind, placebo-controlled trial of sublingual asenapine for acute agitation. Acta Psychiatr Scand. 2014 Jul;130(1):61-8. doi: 10.1111/acps.12262. Epub 2014 Mar 10.
- Individual participant dataSharing planned: Yes. All data available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Pratts, MD principal investigator
St. Joseph's Hospital Health Center - CPEP
Laura Leso, MD principal investigator
St. Joseph's Hospital Health Center - CPEP
David Frey, MD principal investigator
St. Joseph's Hospital Health Center - CPEP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Asenapine in people with Agitation, run by Unity Health Toronto at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale - Excited Component (time frame: Change in PANSS-EC score from baseline to 2 hours post drug/placebo administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01400113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.