A Long-Term Study of JNS007ER in Patien… | Clinical Trial

Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paliperidone extended-release (JNS007ER)

Drug

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 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)

Time frame: 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)

Time frame: 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".

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutical K.K.

Industry

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Mar 23, 2012
Registry last updated: Sep 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed