Schizophrenia Clinical Trial
Official title:
A Long-Term Study of JNS007ER in Patients With Schizophrenia
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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