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 - IMPACT

Janssen-Cilag NV/SA0 个研究点目标入组 0 人开始时间: 2009年9月8日最近更新: 2022年3月28日

试验速览

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•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

•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.

发起方

Janssen-Cilag NV/SA