Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

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


Related Conditions & MeSH terms


NCT number NCT01050478
Study type Interventional
Source Janssen Cilag N.V./S.A.
Contact
Status Completed
Phase Phase 4
Start date March 2010
Completion date December 2011

See also
  Status Clinical Trial Phase
Completed NCT03832257 - Improving Safety of Transitions to Skilled Nursing Care Using Videoconferencing N/A
Completed NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed NCT00186342 - Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies N/A
Recruiting NCT04615065 - Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
Completed NCT02568475 - Involving Nursing Home Residents and Their Families in Acute Care Transfer Decisions N/A
Terminated NCT00563654 - Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up N/A
Terminated NCT00073372 - A Study of Effectiveness and Safety of Abciximab in Patients With Acute Ischemic Stroke (AbESTT-II) Phase 3
Recruiting NCT05708768 - Digital, Innovative, Sustainable, and Knowledge-based Acute Municipal Healthcare Services Illness and Trauma
Completed NCT04571021 - Implementation of the Individual Danish Emergency Process Triage N/A
Completed NCT03982589 - Telomere Length in Relation to Acute Stress Response in Critical Care Patients
Suspended NCT04519086 - The Optimization of a Low-dose CT Protocol in Patients With Suspected Uncomplicated Acute Appendicitis and BMI >30 N/A
Recruiting NCT02688244 - Irrigation Versus Suction in Complicated Acute Appendicitis N/A
Completed NCT02474277 - How Well Does the 30-Second Chair Stand Test Predict Rehabilitation Needs in Acutely Admitted Elderly Patients N/A
Recruiting NCT02422901 - A Long-term Study to Describe the Use of PASCORBIN® 7.5 g in Patients With Vitamin C Deficiency
Completed NCT01278199 - Bronchial Artery Embolization and Medical Measures in Non Severe Acute Hemoptysis of Mild-moderate Abundance N/A
Recruiting NCT05506683 - Improving Nighttime Access to Care and Treatment; Part 2- Ghana N/A
Recruiting NCT06421246 - Activity in Geriatric Patients and Validation of the Danish Version of the Acute Care Mobility Assessment
Completed NCT02912624 - Simple Intensive Care Studies I (SICS-I)
Recruiting NCT02800122 - PAthwAy of Dyspneic patIent in Emergency (PArADIsE)
Completed NCT02915640 - Use of a Mobile Remote Device to Optimize Pediatric Inter-facility Transportation: A Feasibility Study N/A