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Symptomatic Remission and Social Function in Participants Treated With Paliperidone Extended Release (ER)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Paliperidone ER
Sponsored by
Johnson & Johnson Taiwan Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Paliperidone Extended Release

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self)
  • Participant is drug naive or participant's previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons
  • Participants or their legally acceptable representatives had signed an informed consent document indicating that they understand the purpose of and procedures required for the study and were willing to participate in the study
  • Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study and must have a negative urine pregnancy test at screening

Exclusion Criteria:

  • Participants with use of clozapine, paliperidone extended release (ER), any conventional depot neuroleptic or Risperdal CONSTA during the last 3 months
  • Participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities
  • Participants with history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
  • Participants with known hypersensitivity to paliperidone ER or risperidone
  • Participants with inability to swallow the whole study medication tablet with aid of water

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Paliperidone Extended Release (ER)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS)
    The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.
    Percentage of Participants Achieving Improvement in Personal and Social Performance (PSP) Score by at Least One Category on PSP Scale
    The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.

    Secondary Outcome Measures

    Social Functioning Scale (SFS) Score
    The SFS is a 36-item scale designed to assess social functioning in schizophrenia. It assesses abilities and performance in seven areas: social engagement, interpersonal communication, activities of daily living, recreation, social activities, competence at independent living, and occupation/employment. Total score ranges from 1 to 100 where higher score indicates a more favorable health state.

    Full Information

    First Posted
    April 12, 2012
    Last Updated
    December 2, 2013
    Sponsor
    Johnson & Johnson Taiwan Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01577186
    Brief Title
    Symptomatic Remission and Social Function in Participants Treated With Paliperidone Extended Release (ER)
    Official Title
    Symptomatic Remission and Social Function in Patients Treated With Paliperidone ER
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2008 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    June 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johnson & Johnson Taiwan Ltd

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to explore the relationship between achieving symptomatic remission status by means of the 8 items of Positive and Negative Syndrome Scale (PANSS), and personal and social functioning by means of the Personal and Social Performance (PSP) scale in participants treated with flexibly dosed paliperidone ER.
    Detailed Description
    This is an open label (all people know the identity of the intervention), multicenter (when more than one hospital or medical school team work on a medical research study) and prospective (study following participants forward in time) 12-week study. Participants can be either in- or outpatients. The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 0, 4, 8, and 12 (end of treatment or early withdrawal). Throughout the study, participants will receive paliperidone ER in a flexible dosing range of 3 to 12 milligram per day (mg/day). Efficacy will primarily be evaluated by PANSS and PSP scale. Participants' safety will also be monitored throughout the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia
    Keywords
    Schizophrenia, Paliperidone Extended Release

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    480 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Paliperidone Extended Release (ER)
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Paliperidone ER
    Intervention Description
    Participants will receive paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day (mg/day) orally once daily up to Week 12 as per Investigator's discretion.
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS)
    Description
    The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.
    Time Frame
    End of study (Up to Week 12)
    Title
    Percentage of Participants Achieving Improvement in Personal and Social Performance (PSP) Score by at Least One Category on PSP Scale
    Description
    The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.
    Time Frame
    End of study (Up to Week 12)
    Secondary Outcome Measure Information:
    Title
    Social Functioning Scale (SFS) Score
    Description
    The SFS is a 36-item scale designed to assess social functioning in schizophrenia. It assesses abilities and performance in seven areas: social engagement, interpersonal communication, activities of daily living, recreation, social activities, competence at independent living, and occupation/employment. Total score ranges from 1 to 100 where higher score indicates a more favorable health state.
    Time Frame
    End of study (Up to Week 12)
    Other Pre-specified Outcome Measures:
    Title
    Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12
    Description
    The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.
    Time Frame
    Baseline, Week 12
    Title
    Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12
    Description
    The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).
    Time Frame
    Baseline, Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) Participant is drug naive or participant's previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons Participants or their legally acceptable representatives had signed an informed consent document indicating that they understand the purpose of and procedures required for the study and were willing to participate in the study Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study and must have a negative urine pregnancy test at screening Exclusion Criteria: Participants with use of clozapine, paliperidone extended release (ER), any conventional depot neuroleptic or Risperdal CONSTA during the last 3 months Participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities Participants with history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness) Participants with known hypersensitivity to paliperidone ER or risperidone Participants with inability to swallow the whole study medication tablet with aid of water
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Taiwan Ltd Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Taiwan Ltd
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Symptomatic Remission and Social Function in Participants Treated With Paliperidone Extended Release (ER)

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