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A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Paliperidone ER
Sponsored by
Janssen Pharmaceutica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Paliperidone ER, Treatment naive patients, Newly diagnosed patients

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with schizophrenia
  • Patient with Positive and Negative Syndrome Scale (PANSS) score of 80 to 120 at screening
  • Patients who have not taken any antipsychotics in the past, and those were newly diagnosed with schizophrenia who have not taken any antipsychotics for at least one month prior to screening
  • Patient healthy on the basis of a physical examination, laboratory examination, and vital signs
  • Women must have a negative pregnancy test, and agree to practice an effective method of birth control before entry and throughout the study

Exclusion Criteria:

  • Serious unstable medical condition, including known clinically relevant laboratory abnormalities
  • Judged to be at high risk for adverse events, violence or self-harm
  • Inability to swallow the study medication whole with the aid of water (patients may not chew, divide, dissolve, or crush the study medication)
  • Biochemistry results that are out of the laboratory's normal reference range and are deemed to be clinically significant by the investigator
  • Patients with a current use or known history (over the past 6 months) of substance dependence
  • Positive urine drug examination

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Paliperidone ER

    Arm Description

    Outcomes

    Primary Outcome Measures

    The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90)
    The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.

    Secondary Outcome Measures

    Positive and Negative Syndrome Scale (PANSS) Scores at Baseline
    The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
    Positive and Negative Syndrome Scale (PANSS) Scores at Day 90
    The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
    Clinical Global Impression-Severity (CGIS) Scores at Baseline
    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. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)".
    Clinical Global Impression-Severity (CGIS) Scores at Day 90
    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. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)".
    Personal and Social Performance (PSP) Scores at Baseline
    This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.
    Personal and Social Performance (PSP) Scores at Day 90
    This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.
    Patient Satisfaction With Paliperidone Treatment
    Patients will be interviewed to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor).
    Quality of Sleep at Baseline
    The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).
    Quality of Sleep at Day 90
    The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).
    Daytime Drowsiness at Baseline
    The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).
    Daytime Drowsiness at Day 90
    The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).

    Full Information

    First Posted
    May 16, 2012
    Last Updated
    September 19, 2012
    Sponsor
    Janssen Pharmaceutica
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01606228
    Brief Title
    A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients With Schizophrenia
    Official Title
    An Open-Label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly-Dosed Paliperidone ER Among Treatment-Naïve and Newly Diagnosed Patients With Schizophrenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2007 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Janssen Pharmaceutica

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.
    Detailed Description
    This is a single arm (the same intervention is given to all patients), multicenter study that aimed to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among Filipino patients with schizophrenia who have not taken any antipsychotics in the past, and among newly diagnosed schizophrenia patients who have not taken any antipsychotics for at least one month prior to screening. Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Flexible dosing allows the investigators to adjust the dosage of each patient based on the individual needs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia
    Keywords
    Schizophrenia, Paliperidone ER, Treatment naive patients, Newly diagnosed patients

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    188 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Paliperidone ER
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Paliperidone ER
    Intervention Description
    Type= range, unit= mg/day, number= 3 to 12, form= tablet, route= oral use. Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
    Primary Outcome Measure Information:
    Title
    The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90)
    Description
    The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
    Time Frame
    Baseline, Day 90
    Secondary Outcome Measure Information:
    Title
    Positive and Negative Syndrome Scale (PANSS) Scores at Baseline
    Description
    The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
    Time Frame
    Baseline
    Title
    Positive and Negative Syndrome Scale (PANSS) Scores at Day 90
    Description
    The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
    Time Frame
    Day 90
    Title
    Clinical Global Impression-Severity (CGIS) Scores at Baseline
    Description
    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. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)".
    Time Frame
    Baseline
    Title
    Clinical Global Impression-Severity (CGIS) Scores at Day 90
    Description
    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. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)".
    Time Frame
    Day 90
    Title
    Personal and Social Performance (PSP) Scores at Baseline
    Description
    This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.
    Time Frame
    Baseline
    Title
    Personal and Social Performance (PSP) Scores at Day 90
    Description
    This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.
    Time Frame
    Day 90
    Title
    Patient Satisfaction With Paliperidone Treatment
    Description
    Patients will be interviewed to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor).
    Time Frame
    90 days
    Title
    Quality of Sleep at Baseline
    Description
    The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).
    Time Frame
    Baseline
    Title
    Quality of Sleep at Day 90
    Description
    The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).
    Time Frame
    Day 90
    Title
    Daytime Drowsiness at Baseline
    Description
    The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).
    Time Frame
    Baseline
    Title
    Daytime Drowsiness at Day 90
    Description
    The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).
    Time Frame
    Day 90

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed with schizophrenia Patient with Positive and Negative Syndrome Scale (PANSS) score of 80 to 120 at screening Patients who have not taken any antipsychotics in the past, and those were newly diagnosed with schizophrenia who have not taken any antipsychotics for at least one month prior to screening Patient healthy on the basis of a physical examination, laboratory examination, and vital signs Women must have a negative pregnancy test, and agree to practice an effective method of birth control before entry and throughout the study Exclusion Criteria: Serious unstable medical condition, including known clinically relevant laboratory abnormalities Judged to be at high risk for adverse events, violence or self-harm Inability to swallow the study medication whole with the aid of water (patients may not chew, divide, dissolve, or crush the study medication) Biochemistry results that are out of the laboratory's normal reference range and are deemed to be clinically significant by the investigator Patients with a current use or known history (over the past 6 months) of substance dependence Positive urine drug examination
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen Pharmaceutica Clinical Trial
    Organizational Affiliation
    Janssen Pharmaceutica
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients With Schizophrenia

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