drugset / Trial / NCT01050478

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

NCT01050478

Phase 4 Completed 56 enrolled Janssen Cilag N.V./S.A.
NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Publications

  • Results 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.

Drugs

EvaluationDrugModalityDoseRoute
Subject Paliperidone Unknown 6 mg Oral
Subject Paliperidone Unknown 9 mg Oral
Background Lorazepam Small molecule 7.5 mg

Indications

No indication recorded.