A Long-Term Study of JNS007ER in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Paliperidone Palmitate

Criteria

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