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An Open-Label, Prospective, Non-Comparative Study to Evaluate the Efficacy and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia
The purpose of this study is to evaluate the effectiveness and safety of paliperidone palmitate in schizophrenic inpatients who have experienced recent exacerbation of acute schizophrenia (that is within past 4 weeks).
This is an open-label (all people know the identity of the intervention), prospective (looking forward using periodic observations collected predominantly following participant enrollment), non-comparative and multicenter study to evaluate the effectiveness and safety of paliperidone palmitate in acute schizophrenic participants. This study consists of a screening phase (up to 7 days), treatment phase (13 weeks), and a study completion or early withdrawal visit. Safety evaluations will include adverse events, clinical laboratory tests, concomitant medications, physical examination, and vital signs, which will be monitored throughout the study. The total duration of study participation for each participant will be approximately 13 weeks.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Huzhou, China
Shanghai, China
Shantou, China
Suzhou, China
Wenzhou, China
Wuxi, China
Johor Bahru, Malaysia
Kuala Lumpur, Malaysia
Tanjong Rambutan, Malaysia
Busan, South Korea
Start Date
June 22, 2012
Primary Completion Date
December 31, 2013
Completion Date
December 31, 2013
Last Updated
October 28, 2024
212
ACTUAL participants
Paliperidone palmitate
DRUG
Lead Sponsor
Janssen Research & Development, LLC
NCT07455929
NCT06740383
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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