A Long-Term Study of JNS007ER in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Paliperidone extended-release (JNS007ER)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, JNS007ER, Paliperidone extended-release
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paliperidone extended-release (JNS007ER)
Arm Description
Outcomes
Primary Outcome Measures
Incidence of Adverse Events
The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events.
Secondary Outcome Measures
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).
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".
Full Information
NCT ID
NCT01561898
First Posted
March 22, 2012
Last Updated
September 14, 2012
Sponsor
Janssen Pharmaceutical K.K.
1. Study Identification
Unique Protocol Identification Number
NCT01561898
Brief Title
A Long-Term Study of JNS007ER in Patients With Schizophrenia
Official Title
A Long-Term Study of JNS007ER in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Janssen Pharmaceutical K.K.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, JNS007ER, Paliperidone extended-release
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paliperidone extended-release (JNS007ER)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Paliperidone extended-release (JNS007ER)
Intervention Description
Type= range, unit= mg, number= 3-12, form= tablet, route= oral use. JNS007ER within the range of 3, 6, 9 and 12 mg will be orally administered once daily for 48 weeks.
Primary Outcome Measure Information:
Title
Incidence of Adverse Events
Description
The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS)
Description
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).
Time Frame
Baseline, Week 48
Title
Change From Baseline in Clinical Global Impression - Severity (CGI-S)
Description
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".
Time Frame
Baseline, Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K., Japan Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Long-Term Study of JNS007ER in Patients With Schizophrenia
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