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A Long-Term Study of JNS007ER in Patients With Schizophrenia

This study has been completed.
Information provided by:
Janssen Pharmaceutical K.K. Identifier:
First received: March 22, 2012
Last updated: September 14, 2012
Last verified: September 2012
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.

Condition Intervention Phase
Schizophrenia Drug: Paliperidone extended-release (JNS007ER) Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-Term Study of JNS007ER in Patients With Schizophrenia

Resource links provided by NLM:

Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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".

Enrollment: 228
Study Start Date: June 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paliperidone extended-release (JNS007ER) Drug: Paliperidone 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.

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.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01561898

Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
  More Information

Responsible Party: Medical Director, Janssen Pharmaceutical K.K., Japan Identifier: NCT01561898     History of Changes
Other Study ID Numbers: CR012628
JNS007ER-JPN-S32 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
Study First Received: March 22, 2012
Results First Received: August 8, 2012
Last Updated: September 14, 2012

Keywords provided by Janssen Pharmaceutical K.K.:
Paliperidone extended-release

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Paliperidone Palmitate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents processed this record on August 23, 2017