Psychomotor AgitationPhase 4NCT01050478
IMPACT: A Study to Explore the Efficacy and Safety of Paliperidone ER in Patients With Acute Agitation
A Phase 4 study testing Paliperidone ER and Benzodiazepine in people with Psychomotor Agitation and Acute Disease, run by Janssen Cilag N.V./S.A. at 14 sites in Belgium.
Trial summary
This study will investigate the effect of paliperidone ER (in combination with or without benzodiazepines) in patients presenting with symptoms of agitation and/or aggression in the context of psychosis, and will generate data regarding both efficacy and safety in the acute setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychomotor Agitation, Acute Disease
- What is being tested?
- Paliperidone ER and Benzodiazepine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 14 sitesBelgium
- Study dates
- Mar 2010to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient presenting with acute agitation and/or aggression in the context of psychosis, suspected schizophrenia PANSS-EC score >=20 Patient is outpatient in need of hospitalization female patients of childbearing potential must have a negative urine pregnancy test at baseline and further adequate anticonceptive protection signed informed consent
Who cannot join
- Received benzodiazepines 4 hours prior to enrolment Received antipsychotic medication 72 hours prior to enrolment agitation, aggression or violent behaviour that necessitates the use of intramuscular or intravenous medication Patient's preference for intramuscular or intravenous medication Patient judged to be at high risk for suicidal behaviour Pregnant or breast feeding females Patient received clozapine or long-acting injectable antipsychotic during the last 3 months Serious unstable medical condition, including known clinically relevant lab abnormalities History of current symptoms or tardive dyskinesia History of neuroleptic malignant syndrome Participation in an investigational drug trial in the 30 days prior to selection Inability to swallow the study medication whole with the aid of water (chewing, dissolving, dividing or crushing the study medication is not allowed) Patients with a narrowing or blockage of their gastro-intestinal tract Patients with current or known history (past 6 months) of substance dependence according to DSM-IV criteria known hypersensitivity to paliperidone ER or risperidone Employees of the investigator or study centre, persons with direct involvement in the proposed study or other studies under the direction of that investigator or study centre, or family members of the employees or the investigator
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Belgium14 sites
Study site
Bruges
Study site
Brussels
Study site
Dave
Study site
Diest
Study site
Ghent
Study site
Henri-Chapelle
Study site
Heusden
Study site
Kortrijk
Study site
La Louvière
Study site
Liège
Study site
Marchienne-au-Pont
Study site
Ottignies
Study site
Sint-Denijs-Westrem
Study site
Tournai
About this study
Official title: Open-label, Single Arm, Interventional Study to Explore the Efficacy and Safety of Paliperidone ER in the Management of Patients With Acute Agitation and/or Aggression
This study will investigate the effect of paliperidone ER (in combination with or without benzodiazepines) in patients presenting with symptoms of agitation and/or aggression in the context of psychosis, and will generate data regarding both efficacy and safety in the acute setting.
Read the detailed description
Psychomotor agitation that requires hospitalization is a common event during the course of certain major psychiatric disorders, including schizophrenia. Emergency psychiatric services are the first doorway for the control of agitation and behavioural disturbances of the mentally ill in order to avoid dangerousness and aggression towards themselves and/or others. The use of drugs that influence the psychological behaviour (psychotropic drugs) should help to handle agitation and aggression, rapidly rendering people calm and/or sedated without producing distressing or dangerous adverse events, and facilitating extended assessment and definitive treatment. Oral atypical antipsychotics, alone or in combination with a benzodiazepine, are considered first line treatment for patients who present at the emergency ward with mild to moderate psychotic agitation. Paliperidone is a new atypical antipsychotic therapeutic agent for the treatment of schizophrenia. Paliperidone extended release (ER) might be considered as a treatment option for patients presenting with agitation and/or aggression (in combination with short term use of benzodiazepines) because of its fast onset of action and limited or no long term sedating effects. This open-label, single arm, multicenter, interventional descriptive study will collect data on efficacy and safety during first days of treatment with paliperidone ER in patients with acute agitation in the context of psychosis in the psychiatric emergency setting. The assessment of effectiveness/response will be based on Positive And Negative Syndrome Score Exciting Component (PANSS-EC) improvement. Safety evaluations include the incidence of serious and non-serious adverse events. The study will end after 5 days of treatment or at day of discharge from the hospital, whatever comes first. 6 mg (patients with an acute exacerbation of schizophrenia in a real-world setting an initial dose of paliperidone 9 mg once daily may provide optimal clinical efficacy with good tolerability) tablet, oral, once a day during the study duration (5 days).
- Conditions
- Psychomotor Agitation, Acute Disease
- Being tested
- Paliperidone ER, Benzodiazepine
- Keywords
- acute agitation, aggression, psychosis, paliperidone extended release
- Medical subject headings
- Psychomotor Agitation, Acute Disease, Aggression, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone ERDrug
paliperidone ER at 2 dosage levels (6 and 9 mg/day)
BenzodiazepineDrug
Participants may receive the benzodiazepine lorazepam [0-7.5 milligram (mg) per day] as needed for sedation or rescue medication at the investigator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Paliperidone ER | Experimental | Paliperidone ER: recommended dose: 6 mg/day. Can be 9 mg/day for patients with an acute exacerbation of schizophrenia. A benzodiazepine for sedation and/or rescue medication can be added with a maximum of 7.5 mg/day, at the investigators' discretion. Receives: Drug: Paliperidone ER; Drug: Benzodiazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients having an improvement of 40% or more on PANSS-EC
Measured: All of the 8 study visits during the 5-day study duration
Secondary outcomes (5)
Assessing the change from baseline on PANSS-EC (Positive and Negative Syndrome Scale - Exciting Component)
Measured: All of the 8 study visits during the 5-day study duration
Assessing the change from baseline on the OAS (Overt Agression Scale)
Measured: All of the 8 study visits during the 5-day study duration
Assessing disease severity (Global Assessment of Functioning)
Measured: All of the study visits during the 5-day study duration, except study visit 2
Assessing daytime drowsiness (Behaviour Activity Rating Scale)
Measured: All of the 8 study visits during the 5-day study duration
Assessing tolerability and safety by reporting adverse events and vital signs
Measured: All of the 8 study visits during the 5-day study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychomotor AgitationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Cilag N.V./S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag N.V./S.A., Belgium Clinical Trial, Study director, Janssen Cilag N.V./S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050478
- Sponsor's protocol ID
- CR015427
- Other IDs
- R076477SCH3038, 2009-015629-35, 2009
- Status last verified
- Feb 2016
- First submitted
- 14 Jan 2010
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Audenaert K, Godenir F, Geerts P, Van Gils L, Wouters C, Detraux J. IMPACT (Invega in the Management of Patients in the ACute seTting): results from a Belgian study using paliperidone extended-release in the management of psychotic patients with acute agitation and/or aggression. Acta Psychiatrica Belgica 2013 113 (4) 21-30.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single Arm, Interventional Study to Explore the Efficacy and Safety of Paliperidone ER in the Management of Patients With Acute Agitation and/or Aggression
- ClinicalTrials.gov ID
- NCT01050478
- Acronym / sponsor ID
- CR015427
- Conditions
- Psychomotor Agitation, Acute Disease
- Keywords
- acute agitation, aggression, psychosis, paliperidone extended release
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Janssen Cilag N.V./S.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the effect of paliperidone ER (in combination with or without benzodiazepines) in patients presenting with symptoms of agitation and/or aggression in the context of psychosis, and will generate data regarding both efficacy and safety in the acute setting.
Detailed description
Psychomotor agitation that requires hospitalization is a common event during the course of certain major psychiatric disorders, including schizophrenia. Emergency psychiatric services are the first doorway for the control of agitation and behavioural disturbances of the mentally ill in order to avoid dangerousness and aggression towards themselves and/or others. The use of drugs that influence the psychological behaviour (psychotropic drugs) should help to handle agitation and aggression, rapidly rendering people calm and/or sedated without producing distressing or dangerous adverse events, and facilitating extended assessment and definitive treatment. Oral atypical antipsychotics, alone or in combination with a benzodiazepine, are considered first line treatment for patients who present at the emergency ward with mild to moderate psychotic agitation. Paliperidone is a new atypical antipsychotic therapeutic agent for the treatment of schizophrenia. Paliperidone extended release (ER) might be considered as a treatment option for patients presenting with agitation and/or aggression (in combination with short term use of benzodiazepines) because of its fast onset of action and limited or no long term sedating effects. This open-label, single arm, multicenter, interventional descriptive study will collect data on efficacy and safety during first days of treatment with paliperidone ER in patients with acute agitation in the context of psychosis in the psychiatric emergency setting. The assessment of effectiveness/response will be based on Positive And Negative Syndrome Score Exciting Component (PANSS-EC) improvement. Safety evaluations include the incidence of serious and non-serious adverse events. The study will end after 5 days of treatment or at day of discharge from the hospital, whatever comes first. 6 mg (patients with an acute exacerbation of schizophrenia in a real-world setting an initial dose of paliperidone 9 mg once daily may provide optimal clinical efficacy with good tolerability) tablet, oral, once a day during the study duration (5 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paliperidone ER | Experimental | Drug: Paliperidone ER, Drug: BenzodiazepinePaliperidone ER: recommended dose: 6 mg/day. Can be 9 mg/day for patients with an acute exacerbation of schizophrenia. A benzodiazepine for sedation and/or rescue medication can be added with a maximum of 7.5 mg/day, at the investigators' discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient presenting with acute agitation and/or aggression in the context of psychosis, suspected schizophrenia PANSS-EC score >=20 Patient is outpatient in need of hospitalization female patients of childbearing potential must have a negative urine pregnancy test at baseline and further adequate anticonceptive protection signed informed consent
Key exclusion criteria (1 listed)
- Received benzodiazepines 4 hours prior to enrolment Received antipsychotic medication 72 hours prior to enrolment agitation, aggression or violent behaviour that necessitates the use of intramuscular or intravenous medication Patient's preference for intramuscular or intravenous medication Patient judged to be at high risk for suicidal behaviour Pregnant or breast feeding females Patient received clozapine or long-acting injectable antipsychotic during the last 3 months Serious unstable medical condition, including known clinically relevant lab abnormalities History of current symptoms or tardive dyskinesia History of neuroleptic malignant syndrome Participation in an investigational drug trial in the 30 days prior to selection Inability to swallow the study medication whole with the aid of water (chewing, dissolving, dividing or crushing the study medication is not allowed) Patients with a narrowing or blockage of their gastro-intestinal tract Patients with current or known history (past 6 months) of substance dependence according to DSM-IV criteria known hypersensitivity to paliperidone ER or risperidone Employees of the investigator or study centre, persons with direct involvement in the proposed study or other studies under the direction of that investigator or study centre, or family members of the employees or the investigator
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 |
|---|---|---|
| Paliperidone ERpaliperidone ER at 2 dosage levels (6 and 9 mg/day) | Drug | Paliperidone ER |
| BenzodiazepineParticipants may receive the benzodiazepine lorazepam [0-7.5 milligram (mg) per day] as needed for sedation or rescue medication at the investigator's discretion. | Drug | Paliperidone ER |
Primary outcome
Number of patients having an improvement of 40% or more on PANSS-EC
Time frame: All of the 8 study visits during the 5-day study duration
5 secondary outcomes
Assessing the change from baseline on PANSS-EC (Positive and Negative Syndrome Scale - Exciting Component)
Time frame: All of the 8 study visits during the 5-day study duration
Assessing the change from baseline on the OAS (Overt Agression Scale)
Time frame: All of the 8 study visits during the 5-day study duration
Assessing disease severity (Global Assessment of Functioning)
Time frame: All of the study visits during the 5-day study duration, except study visit 2
Assessing daytime drowsiness (Behaviour Activity Rating Scale)
Time frame: All of the 8 study visits during the 5-day study duration
Assessing tolerability and safety by reporting adverse events and vital signs
Time frame: All of the 8 study visits during the 5-day study duration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Results publicationAudenaert K, Godenir F, Geerts P, Van Gils L, Wouters C, Detraux J. IMPACT (Invega in the Management of Patients in the ACute seTting): results from a Belgian study using paliperidone extended-release in the management of psychotic patients with acute agitation and/or aggression. Acta Psychiatrica Belgica 2013 113 (4) 21-30.
- Open-label, single arm, interventional study to explore the efficacy and safety of paliperidone ER in the management of patients with acute agitation and/or aggressionLink provided by the sponsor.
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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.
Janssen-Cilag N.V./S.A., Belgium Clinical Trial study director
Janssen Cilag N.V./S.A.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paliperidone ER and Benzodiazepine in people with Psychomotor Agitation and Acute Disease, run by Janssen Cilag N.V./S.A. at 14 sites in Belgium.
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 1 inclusion and 1 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 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Belgium. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients having an improvement of 40% or more on PANSS-EC (time frame: All of the 8 study visits during the 5-day study duration). 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 NCT01050478, 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 9 Feb 2016; AzTrials last refreshed its copy on 1 Nov 2026.