IMPACT: A Study to Explore the Efficacy and Safety of Paliperidone ER in Patients With Acute Agitation

Sponsor

Janssen Cilag N.V./S.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT01050478

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

3.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Psychomotor Agitation Acute Disease	Drug: Paliperidone ER Drug: Benzodiazepine	Phase 4

Detailed 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

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paliperidone ER Paliperidone ER: recommended dose: 6 mg/day. Can be 9 mg/day for patients with an acute exacerbation of schizophrenia. A benzodiazepine for sedation and/or rescue medication can be added with a maximum of 7.5 mg/day, at the investigators' discretion.	Drug: Paliperidone ER paliperidone ER at 2 dosage levels (6 and 9 mg/day) Drug: Benzodiazepine Participants may receive the benzodiazepine lorazepam [0-7.5 milligram (mg) per day] as needed for sedation or rescue medication at the investigator's discretion.

Arm

Intervention/Treatment

Experimental: Paliperidone ER

Paliperidone ER: recommended dose: 6 mg/day. Can be 9 mg/day for patients with an acute exacerbation of schizophrenia. A benzodiazepine for sedation and/or rescue medication can be added with a maximum of 7.5 mg/day, at the investigators' discretion.

Drug: Paliperidone ER

paliperidone ER at 2 dosage levels (6 and 9 mg/day)

Drug: Benzodiazepine

Participants may receive the benzodiazepine lorazepam [0-7.5 milligram (mg) per day] as needed for sedation or rescue medication at the investigator's discretion.

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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]
Assessing the change from baseline on the OAS (Overt Agression Scale) [All of the 8 study visits during the 5-day study duration]
Assessing disease severity (Global Assessment of Functioning) [All of the study visits during the 5-day study duration, except study visit 2]
Assessing daytime drowsiness (Behaviour Activity Rating Scale) [All of the 8 study visits during the 5-day study duration]
Assessing tolerability and safety by reporting adverse events and vital signs [All of the 8 study visits during the 5-day study duration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	Country
1	Brugge	Belgium
2	Brussel	Belgium
3	Bruxelles	Belgium
4	Diest	Belgium
5	Gent	Belgium
6	Henri-Chapelle	Belgium
7	Heusden	Belgium
8	Kortrijk	Belgium
9	La Louvière	Belgium
10	Liège	Belgium
11	Marchienne-Au-Pont	Belgium
12	Namur (Dave)	Belgium
13	Ottignies	Belgium
14	Sint-Denijs-Westrem	Belgium
15	Tournai	Belgium