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The purpose of this study is to assess the safety of JNS007ER 3-12 mg once daily in patients with schizophrenia over a long term period.
This is a 48-week, multicenter, open-label (all people know the identity of the intervention), non-controlled, arbitrary-dose study. The patients included in this study are those who participated in the preceding double-blind (neither physician nor patient knows the treatment that the patient receives) comparative trial (study JNS007ER-JPN-S31) of JNS007ER and completed the study, or those who remained in the study up to the evaluation at 2 weeks and discontinued the study after that for insufficient treatment efficacy. The study will assess the safety of JNS007ER in the clinical recommended dose range in a long term treatment. The dosage will be started at 6 mg/day, and it can be increased or decreased 3 mg at a time depending on the patient's symptom within the range of 3 mg/day to 12 mg/day. For dose adjustments, the investigator will evaluate the psychiatric symptoms before defining the dose change. Detailed Description: Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures.
Age
20 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
June 1, 2006
Primary Completion Date
October 1, 2008
Completion Date
October 1, 2008
Last Updated
September 28, 2012
228
ACTUAL participants
Paliperidone extended-release (JNS007ER)
DRUG
Lead Sponsor
Janssen Pharmaceutical K.K.
NCT07455929
NCT06740383
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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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