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.
Status | Completed |
Enrollment | 228 |
Est. completion date | October 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Pharmaceutical K.K. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Adverse Events | The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events. | 48 weeks | No |
Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) | PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). | Baseline, Week 48 | No |
Secondary | Change From Baseline in Clinical Global Impression - Severity (CGI-S) | The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". | Baseline, Week 48 | No |
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