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A Long-Term Study of JNS007ER in Patients With Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01561898
First Posted: March 23, 2012
Last Update Posted: September 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Janssen Pharmaceutical K.K.
  Purpose
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561898


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

Responsible Party: Medical Director, Janssen Pharmaceutical K.K., Japan
ClinicalTrials.gov Identifier: NCT01561898     History of Changes
Other Study ID Numbers: CR012628
JNS007ER-JPN-S32 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Submitted: March 22, 2012
First Posted: March 23, 2012
Results First Submitted: August 8, 2012
Results First Posted: September 10, 2012
Last Update Posted: September 28, 2012
Last Verified: September 2012

Keywords provided by Janssen Pharmaceutical K.K.:
Schizophrenia
JNS007ER
Paliperidone extended-release

Additional relevant MeSH terms:
Schizophrenia
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