Acute Disease Clinical Trial
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
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Patient presenting with acute agitation and/or aggression in the context of psychosis, suspected schizophrenia PANSS-EC score >=20 Patient is outpatient in need of hospitalization female patients of childbearing potential must have a negative urine pregnancy test at baseline and further adequate anticonceptive protection signed informed consent Exclusion Criteria: Received benzodiazepines 4 hours prior to enrolment Received antipsychotic medication 72 hours prior to enrolment agitation, aggression or violent behaviour that necessitates the use of intramuscular or intravenous medication Patient's preference for intramuscular or intravenous medication Patient judged to be at high risk for suicidal behaviour Pregnant or breast feeding females Patient received clozapine or long-acting injectable antipsychotic during the last 3 months Serious unstable medical condition, including known clinically relevant lab abnormalities History of current symptoms or 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 (chewing, dissolving, dividing or crushing the study medication is not allowed) Patients with a narrowing or blockage of their gastro-intestinal tract Patients with current or known history (past 6 months) of substance dependence according to DSM-IV criteria known hypersensitivity to paliperidone ER or risperidone Employees of the investigator or study centre, persons with direct involvement in the proposed study or other studies under the direction of that investigator or study centre, or family members of the employees or the investigator |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Cilag N.V./S.A. |
Belgium,
Audenaert K, Godenir F, Geerts P, Van Gils L, Wouters C, Detraux J. IMPACT (Invega in the Management of Patients in the ACute seTting): results from a Belgian study using paliperidone extended-release in the management of psychotic patients with acute agi
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients having an improvement of 40% or more on PANSS-EC | All of the 8 study visits during the 5-day study duration | No | |
Secondary | Assessing the change from baseline on PANSS-EC (Positive and Negative Syndrome Scale - Exciting Component) | All of the 8 study visits during the 5-day study duration | No | |
Secondary | Assessing the change from baseline on the OAS (Overt Agression Scale) | All of the 8 study visits during the 5-day study duration | No | |
Secondary | Assessing disease severity (Global Assessment of Functioning) | All of the study visits during the 5-day study duration, except study visit 2 | No | |
Secondary | Assessing daytime drowsiness (Behaviour Activity Rating Scale) | All of the 8 study visits during the 5-day study duration | No | |
Secondary | Assessing tolerability and safety by reporting adverse events and vital signs | All of the 8 study visits during the 5-day study duration | Yes |
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