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Tolerability, Safety and Treatment Response of Flexible Doses of Paliperidone ER in Acutely Exacerbated Subjects With Schizophrenia
The purpose of this study is to evaluate the tolerability, safety and treatment response of flexible doses of paliperidone extended-release (ER; designed to slowly release a drug in the body over an extended period of time) tablets in participants with acute schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
This is an open-label (all people know the identity of the intervention), single-arm (getting one dose of medicine), multi-center (conducted in more than 1 center) study to evaluate tolerability, safety and efficacy of flexible daily doses of paliperidone ER in participants with acute schizophrenia. All participants will be given paliperidone ER once daily at a dose of 3, 6, 9, or 12 milligram (mg) tablets orally depending on Investigator's discretion, based on participant's clinical response and tolerability towards paliperidone ER. The duration of the core phase of the treatment will be 6 weeks and the participants who will complete this phase, respond well and would like to continue, will be eligible to be enrolled in an extension phase, which is no longer than 12 months. Efficacy will primarily be evaluated by treatment response evaluated through total Positive and Negative Syndrome Scale (PANSS) score. Participants' safety will be monitored throughout the study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Zagreb, Croatia
Dieppe, France
La Charité-sur-Loire, France
Metz, France
Augsburg, Germany
Bonn, Germany
Mainz, Germany
Mannheim, Germany
München, Germany
Rostock, Germany
Start Date
July 1, 2007
Primary Completion Date
May 1, 2008
Completion Date
May 1, 2009
Last Updated
August 2, 2013
294
ACTUAL participants
Paliperidone
DRUG
Lead Sponsor
Janssen-Cilag International NV
NCT07455929
NCT06740383
Data Source & Attribution
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