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

NCT01050478 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2016-02-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Janssen Cilag N.V./S.A.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01050478 on ClinicalTrials.gov