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

Condition(s) targeted: Psychomotor Agitation; Acute Disease

Intervention: Paliperidone ER (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Janssen Cilag N.V./S.A.

Official(s) and/or principal investigator(s):
Janssen-Cilag N.V./S.A., Belgium Clinical Trial, Study Director, Affiliation: Janssen Cilag N.V./S.A.

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com

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.

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of patients having an improvement of 40% or more on PANSS-EC

Secondary outcome:

Assessing the change from baseline on PANSS-EC (Positive and Negative Syndrome Scale - Exciting Component)

Assessing the change from baseline on the OAS (Overt Agression Scale)

Assessing disease severity (Global Assessment of Functioning)

Assessing daytime drowsiness (Behaviour Activity Rating Scale)

Assessing tolerability and safety by reporting adverse events and vital signs

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).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com

Antwerpen, Belgium; Withdrawn

Brugge, Belgium; Recruiting

Brugge, Belgium; Completed

Brussel, Belgium; Recruiting

Bruxelles, Belgium; Withdrawn

Bruxelles, Belgium; Recruiting

Diest, Belgium; Recruiting

Gent, Belgium; Recruiting

Henri-Chapelle, Belgium; Recruiting

Heusden, Belgium; Completed

Kortenberg, Belgium; Withdrawn

Kortrijk, Belgium; Recruiting

Kortrijk, Belgium; Completed

La Louvière, Belgium; Recruiting

Liège, Belgium; Completed

Marchienne-Au-Pont, Belgium; Recruiting

Mons, Belgium; Withdrawn

Mortsel, Belgium; Withdrawn

Namur (Dave), Belgium; Recruiting

Ottignies, Belgium; Completed

Roeselare, Belgium; Withdrawn

Sint-Denijs-Westrem, Belgium; Recruiting

Sint-Gillis-Dendermonde, Belgium; Withdrawn

Tienen, Belgium; Withdrawn

Tournai, Belgium; Recruiting

Veurne, Belgium; Withdrawn

Zoersel, Belgium; Withdrawn

To learn how to participate in this trial please click here.

To learn how to participate in this trial please click here.

Starting date: January 2010
Last updated: November 29, 2011