A Long-Term Study of JNS007ER in Patients With Schizophrenia
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Janssen Pharmaceutical K.K.
- Enrollment
- 228
- Primary Endpoint
- Incidence of Adverse Events
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Paliperidone extended-release (JNS007ER)
Intervention: Paliperidone extended-release (JNS007ER) (Drug)
Outcomes
Primary Outcomes
Incidence of Adverse Events
Time Frame: 48 weeks
The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events.
Secondary Outcomes
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS)(Baseline, Week 48)
- Change From Baseline in Clinical Global Impression - Severity (CGI-S)(Baseline, Week 48)