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

NCT01050478 | Completed Phase 4

• 3 other identifiers: CR015427R076477SCH30382009-015629-35
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 14

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.

Conditions

Psychomotor Agitation; Acute Disease

Keywords

acute agitation; aggression; psychosis; paliperidone extended release

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

Paliperidone ER

EXPERIMENTAL

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; Drug: Benzodiazepine

Interventions

Paliperidone ER DRUG

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

Paliperidone ER

Benzodiazepine DRUG

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.

Paliperidone ER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Cilag N.V./S.A.: lead

Study Sites (14)

Unknown Facility

Bruges, Belgium

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Dave, Belgium

Location

Unknown Facility

Diest, Belgium

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Henri-Chapelle, Belgium

Location

Unknown Facility

Heusden, Belgium

Location

Unknown Facility

Kortrijk, Belgium

Location

Unknown Facility

La Louvière, Belgium

Location

Unknown Facility

Liège, Belgium

Location

Unknown Facility

Marchienne-au-Pont, Belgium

Location

Unknown Facility

Ottignies, Belgium

Location

Unknown Facility

Sint-Denijs-Westrem, Belgium

Location

Unknown Facility

Tournai, Belgium

Location

Related Publications (1)

• 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 agitation and/or aggression. Acta Psychiatrica Belgica 2013 113 (4) 21-30.

  RESULT

Related Links

• 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

MeSH Terms

Conditions

Psychomotor Agitation; Acute Disease; Aggression; Psychotic Disorders

Interventions

Paliperidone Palmitate; Benzodiazepines

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Social Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Janssen-Cilag N.V./S.A., Belgium Clinical Trial

  Janssen Cilag N.V./S.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2010
• First Posted: January 15, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 9, 2016

Record last verified: 2016-02

Locations

BE (14)