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

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.

Study Overview

• Status: Completed
• Conditions: Psychomotor Agitation; Acute Disease
• Intervention / Treatment: Drug: Paliperidone ER; Drug: Benzodiazepine

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
• Enrollment (Actual): 56
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients having an improvement of 40% or more on PANSS-EC	All of the 8 study visits during the 5-day study duration

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessing the change from baseline on PANSS-EC (Positive and Negative Syndrome Scale - Exciting Component)	All of the 8 study visits during the 5-day study duration
Assessing the change from baseline on the OAS (Overt Agression Scale)	All of the 8 study visits during the 5-day study duration
Assessing disease severity (Global Assessment of Functioning)	All of the study visits during the 5-day study duration, except study visit 2
Assessing daytime drowsiness (Behaviour Activity Rating Scale)	All of the 8 study visits during the 5-day study duration
Assessing tolerability and safety by reporting adverse events and vital signs	All of the 8 study visits during the 5-day study duration

Collaborators and Investigators

• Sponsor: Janssen Cilag N.V./S.A.
• Investigators: Study Director: Janssen-Cilag N.V./S.A., Belgium Clinical Trial, Janssen Cilag N.V./S.A.

Publications and helpful links

General 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.

Helpful Links

• 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 record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: January 14, 2010
• First Submitted That Met QC Criteria: January 14, 2010
• First Posted (Estimate): January 15, 2010

Study Record Updates

• Last Update Posted (Estimate): February 9, 2016
• Last Update Submitted That Met QC Criteria: February 8, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: psychosis; aggression; acute agitation; paliperidone extended release
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease Attributes; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation; Acute Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Paliperidone Palmitate
• Other Study ID Numbers: CR015427; R076477SCH3038 (Other Identifier: Janssen); 2009-015629-35 (EudraCT Number)