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Effectiveness, Safety and Tolerability of Flexibly Dosed Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics and With Acute Symptom of Schizophrenia: A 13-Week, Open-label, Single-arm, Multicenter, Prospective, Interventional Study Followed by a Naturalistic Additional 1 Year Follow up
The purpose of this study is to assess the effectiveness, safety and tolerability of flexibly dosed paliperidone palmitate in patients with schizophrenia previously unsuccessfully treated by oral antipsychotics and with acute symptom of schizophrenia.
This is a 13-week, open-label (all people know the identity of the intervention), single-arm (one group of patients), multicenter, prospective, interventional study in Chinese patients. In a prospective, interventional study, the patients identified receive a treatment during the course of the research study and are followed forward in time for the outcome of the study. In China, there is still insufficient information about effectiveness, tolerability, and dosage strategy for directly switching from previous oral antipsychotics (drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders) in patients with acute symptoms. Acute symptoms are quick and severe form of illness in its early stage. In addition, there is also lack of information about bridging acute phase to long-term treatment. In this study, patients with multiple types of acute schizophrenia will be recruited and will receive Sustenna (paliperidone palmitate) treatments for 13 weeks. After the acute treatment, the patients will continue to receive the prescribed medication and will be followed up for an additional 52 weeks to assess the outcomes related to long-term treatment.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Baoding, China
Beijing, China
Chengdu, China
Chongqing, China
Fuzhou, China
Guangzhou, China
Hangzhou, China
Jinan, China
Nanjing, China
Qingdao, China
Start Date
November 1, 2012
Primary Completion Date
December 1, 2014
Completion Date
December 1, 2014
Last Updated
January 26, 2016
617
ACTUAL participants
Paliperidone Palmitate
DRUG
Lead Sponsor
Xian-Janssen Pharmaceutical Ltd.
NCT07455929
NCT06740383
Data Source & Attribution
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