Clinical trial NCT01561898: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
JNS007ER
Paliperidone extended-release
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 228
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: 48 weeks
Secondary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline, Week 48
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S)
timeFrame: Baseline, Week 48
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: