IMPACT: A Study to Explore the Efficacy and Safety of Paliperidone ER in Patients With Acute Agitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01050478
Recruitment Status : Completed
First Posted : January 15, 2010
Last Update Posted : February 9, 2016
Information provided by (Responsible Party):
Janssen Cilag N.V./S.A.

Brief 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.

Condition or disease Intervention/treatment Phase
Psychomotor Agitation Acute Disease Drug: Paliperidone ER Drug: Benzodiazepine Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Paliperidone ER
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.
Drug: Paliperidone ER
paliperidone ER at 2 dosage levels (6 and 9 mg/day)
Drug: Benzodiazepine
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Assessing disease severity (Global Assessment of Functioning) [ Time Frame: All of the study visits during the 5-day study duration, except study visit 2 ]
  4. Assessing daytime drowsiness (Behaviour Activity Rating Scale) [ Time Frame: All of the 8 study visits during the 5-day study duration ]
  5. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01050478

Brugge, Belgium
Brussel, Belgium
Bruxelles, Belgium
Diest, Belgium
Gent, Belgium
Henri-Chapelle, Belgium
Heusden, Belgium
Kortrijk, Belgium
La Louvière, Belgium
Liège, Belgium
Marchienne-Au-Pont, Belgium
Namur (Dave), Belgium
Ottignies, Belgium
Sint-Denijs-Westrem, Belgium
Tournai, Belgium
Sponsors and Collaborators
Janssen Cilag N.V./S.A.
Study Director: Janssen-Cilag N.V./S.A., Belgium Clinical Trial Janssen Cilag N.V./S.A.

Additional Information:
Publications of Results:
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.

Responsible Party: Janssen Cilag N.V./S.A. Identifier: NCT01050478     History of Changes
Other Study ID Numbers: CR015427
R076477SCH3038 ( Other Identifier: Janssen )
2009-015629-35 ( EudraCT Number )
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016

Keywords provided by Janssen Cilag N.V./S.A.:
acute agitation
paliperidone extended release

Additional relevant MeSH terms:
Psychomotor Agitation
Acute Disease
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Disease Attributes
Pathologic Processes
Paliperidone Palmitate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents