A Long-Term Study of JNS007ER in Patients With Schizophrenia

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.

Inclusion Criteria:

• Patients diagnosed with schizophrenia
• Patients who have given their own consent in writing to participate in the study
• Patients untreated with antipsychotics within 28 days before the screening test
• Patients who have completed Study JNS007ER-JPN-S31, or those who continued the study at least up to the evaluation at 2 weeks and subsequently discontinued the study due to insufficient efficacy
• Patients participating in Study JNS007ER-JPN-S31 and whose ratio of treatment to the evaluation at 2 weeks is ≥75%

Exclusion Criteria:

• Patients diagnosed with a mental disease other than schizophrenia
• A total PANSS score > 120 at baseline
• Substance-related disorders
• Parkinson's disease complications
• Current or a past history of convulsive disease such as epilepsy
• Current or a past history of cerebrovascular accident
• Diabetes mellitus
• Significant hepatic or renal impairment
• Significant cardiovascular disorders
• Abnormal results of hematological examination, blood chemistry test and urinalysis at screening
• Pregnant women, breast-feeding mothers, and patients who wish pregnancy during the study period or those whose pregnancy test at screening was positive
• Contraindications to risperidone products
• Patients who discontinued Study JNS007ER-JPN-S31 due to an adverse event not related to the underlying disease
• Patients judged inadequate by the investigator to participate in the study