Subject presenting with acute agitation and/or agression in the context of psychosis, suspected schizophrenia
Conditions
Interventions
Trade Name: Invega
Product Name: paliperidone ER 6 mg
Product Code: R076477
Pharmaceutical Form: Capsule*
Trade Name: Invega
Product Name: paliperidone ER 9 mg
Product Code: R076477
Pharmaceutical Fo
Sponsors
Janssen-Cilag NV/SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject presenting with acute agitation and/or agression in the context of psychosis, suspected schizophrenia; • A score of 20 or above at the PANSS-EC; • Male or female, aged = 18; • Subject is outpatient in need of hospitalization, according to physician’s discretion; • Female patients of childbearing potential must have a negative urine pregnancy test at baseline and further adequate anticonceptive protection; • Signed Informed Consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Received benzodiazepines 4 hours prior to enrolment; • Received antipsychotic medication 72 hours prior to enrolment; • Agitation, aggression or violent behavior that necessitates the use of intramuscular or intravenous medication; • Patient’s preference for intramuscular or intravenous treatment; • Patient judged to be at high risk for suicidal behavior; • Pregnant or breast feeding female; • Subject received clozapine or a long-acting injectable antipsychotic during the last 3 months; • Serious unstable medical condition, including known clinically relevant laboratory abnormalities; • History or current symptoms of 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 (subjects may not chew, divide, dissolve, or crush the study medication, as this may affect the release profile); • Subjects with a narrowing or blockage of their gastro-intestinal tract; • Subjects with current or known history (over the past 6 months) of substance dependence (except for nicotine and caffeine dependence) according to DSM-IV criteria; • Known hypersensitivity to paliperidone ER or risperidone • Employees of the investigator or study center, persons with direct involvement in the proposed study or other studies under the direction of that investigator or study center, or family members of the employees or the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This open-label, single arm, interventional study will collect data on efficacy and safety during first days of treatment with paliperidone ER in patients with acute agitation and/or aggression in the context of psychosis in the psychiatric emergency setting. Primary objective will be the number of patients having an improvement of 40 % or more on PANSS-EC (= response) at day 6 or early termination compared to baseline. ;Secondary Objective: To explore efficacy, tolerability and safety of the use of paliperidone ER in patients presenting with symptoms of agitation and/or aggression in the context of psychosis. This is done by: •assessing the change from baseline on the PANSS-EC; •assessing the change from baseline on the OAS (Overt Aggression Scale); •assessing the change from baseline on disease severity (Global Assessment of functioning [GAF]); •differentiate between extreme agitation and extreme sedation (Behavioural Activity Rating Scale , a 7-point categorical evaluation scale •assessing tolerability and safety by reporting adverse events (AEs) and vital signs. •assessing the use of lorazepam. The most likely psychiatric diagnosis, based on DSM-IV criteria, will be collected at end of trial. ;Primary end point(s): The primary efficacy criterion will be the response rate at endpoint (defined as a 40% improvement of PANSS-EC baseline versus endpoint) | — |
Countries
Belgium
Outcome results
None listed