E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subject presenting with acute agitation and/or agression in the context of psychosis, suspected schizophrenia |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 20 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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After 5 days of treatment per subject, the trial ends |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |