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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary: 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 efficac
Sponsor: Janssen Cilag N.V./S.A.

Current 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Janssen Cilag N.V./S.A.

Dates:
Date Received: January 14, 2010
Date Started: March 2010
Date Completion:
Last Updated: February 8, 2016
Last Verified: February 2016