Schizophrenia
Conditions
Keywords
Schizophrenia, JNS007ER, Paliperidone extended-release
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.
Interventions
DRUGPaliperidone extended-release (JNS007ER)
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.
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | 48 weeks | The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) | Baseline, Week 48 | 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) | Baseline, Week 48 | 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. |
Participant flow
Recruitment details
This study comprises patients who have participated in previous study JNS007ER-JPN-S31 (NCT00396565) and new patients. New patients were classified as group NO/PAL. Patients entering from study JNS007ER-JPN-S31 were classified according to their origin groups: placebo group (PLA/PAL), paliperidone group (PAL/PAL), and olanzapine group (OLZ/PAL).
Participants by arm
| Arm | Count |
|---|---|
| NO/PAL Group NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. | 7 |
| PLA/PAL Group PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. | 92 |
| PAL/PAL Group PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. | 97 |
| OLZ/PAL OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg. | 32 |
| Total | 228 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 19 | 14 | 9 |
| Overall Study | Lack of Efficacy | 0 | 8 | 10 | 5 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 1 | 5 | 7 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 8 | 12 | 5 |
| Overall Study | Worsening of complications | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | NO/PAL Group | PLA/PAL Group | PAL/PAL Group | OLZ/PAL | Total |
|---|---|---|---|---|---|
| Age Continuous | 35.6 years STANDARD_DEVIATION 14.8 | 46.6 years STANDARD_DEVIATION 15.5 | 42.0 years STANDARD_DEVIATION 14.1 | 46.3 years STANDARD_DEVIATION 14 | 44.3 years STANDARD_DEVIATION 14.9 |
| Sex: Female, Male Female | 3 Participants | 44 Participants | 46 Participants | 20 Participants | 113 Participants |
| Sex: Female, Male Male | 4 Participants | 48 Participants | 51 Participants | 12 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 222 / 228 |
| serious Total, serious adverse events | 10 / 228 |
Outcome results
Primary
Incidence of Adverse Events
The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events.
Time frame: 48 weeks
Population: Intent-to-treat (ITT) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NO/PAL | Incidence of Adverse Events | 97.4 percentage of patients |
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.
Time frame: Baseline, Week 48
Population: Intent-to-treat (ITT) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NO/PAL | Change From Baseline in Clinical Global Impression - Severity (CGI-S) | -0.6 scores on a scale | Standard Deviation 1.27 |
| PLA/PAL Group | Change From Baseline in Clinical Global Impression - Severity (CGI-S) | -0.6 scores on a scale | Standard Deviation 1.2 |
| PAL/PAL Group | Change From Baseline in Clinical Global Impression - Severity (CGI-S) | -0.7 scores on a scale | Standard Deviation 1.24 |
| OLZ/PAL | Change From Baseline in Clinical Global Impression - Severity (CGI-S) | 0.1 scores on a scale | Standard Deviation 1.01 |
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).
Time frame: Baseline, Week 48
Population: Intent-to-treat (ITT) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NO/PAL | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) | -13.4 scores on a scale | Standard Deviation 31.93 |
| PLA/PAL Group | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) | -11.1 scores on a scale | Standard Deviation 20.84 |
| PAL/PAL Group | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) | -17.2 scores on a scale | Standard Deviation 22.15 |
| OLZ/PAL | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) | 2.8 scores on a scale | Standard Deviation 20.67 |