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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Cilag N.V./S.A.
ClinicalTrials.gov Identifier:
NCT01050478
First received: January 14, 2010
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Psychomotor Agitation
Acute Disease
Drug: Paliperidone ER
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Janssen Cilag N.V./S.A.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Assessing disease severity (Global Assessment of Functioning) [ Time Frame: All of the study visits during the 5-day study duration, except study visit 2 ] [ Designated as safety issue: No ]
  • Assessing daytime drowsiness (Behaviour Activity Rating Scale) [ Time Frame: All of the 8 study visits during the 5-day study duration ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient presenting with acute agitation and/or aggression in the context of psychosis, suspected schizophrenia
  • PANSS-EC score >=20
  • age >18
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050478

Locations
Belgium
Brugge, Belgium
Brussel, 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.
Investigators
Study Director: Janssen-Cilag N.V./S.A., Belgium Clinical Trial Janssen Cilag N.V./S.A.
  More Information

No publications provided

Responsible Party: Janssen Cilag N.V./S.A.
ClinicalTrials.gov Identifier: NCT01050478     History of Changes
Other Study ID Numbers: CR015427
Study First Received: January 14, 2010
Last Updated: December 20, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Ethics Committee

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

Additional relevant MeSH terms:
Acute Disease
Psychomotor Agitation
Disease Attributes
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
9-hydroxy-risperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 31, 2014