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Paliperidone Extended Release in Schizophrenia Participants With Duration of Illness Less Than 10 Years

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Paliperidone ER
Sponsored by
Janssen-Cilag S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants meet the Diagnostic and Statistical Manual of Mental Disorders Fourth 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)
  • Positive and Negative Syndrome Scale (PANSS) total score at Baseline of greater than equal to 70 and less than equal to 100
  • Participants who need to be switched from the current oral antipsychotic therapy because of lack of efficacy or side effects
  • Participants followed as outpatients
  • Female participants must be postmenopausal for at least 1 year, surgically sterile or, if sexually active, be practicing an effective method of birth control and female participants of childbearing potential must also have a negative urine pregnancy test at Baseline

Exclusion Criteria:

  • Acute psychotic relapse that requires hospitalization and first antipsychotic treatment ever
  • Participants who had received clozapine during the previous 3 months
  • History or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body) and neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
  • Pregnant or breast-feeding female
  • Participated in an investigational drug trial in the previous 30 days

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Paliperidone ER

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 13
    The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) 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 and ranges from 30 to 210, higher scores indicate worsening.

    Secondary Outcome Measures

    Change in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 13
    The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
    Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 13
    The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
    Change in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 13
    The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).
    Percentage of Participants With Greater Than or Equal to 30 Percent Treatment Response in Total Positive and Negative Syndrome Scale (PANSS) Score
    The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) 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 and ranges from 30 to 210, higher scores indicate worsening.
    Change From Baseline in Subjective Well-being Under Neuroleptic (SWN 20) Scale at Week 13
    The SWN 20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood.
    Change From Baseline in Drug Attitude Inventory (DAI 30) Scale at Week 13
    The DAI is a 30-item self-rating inventory that focuses on subjective effects of neuroleptic medications in participants with schizophrenia. There are 15 items that are scored as true and 15 scored as false if the person is fully compliant (positive subjective response). Positive answers score as +1, negative answers score as - 1. Questionnaire allows identifying participants at high risk of low compliance. The total score may vary from -30 to +30 with a high total final score is a positive subjective response (compliant) and a low total score is a negative subjective response (non-compliant).
    Clinical Global Impression-Severity Scale (CGI-S)
    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 participant. 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 participants. Higher scores indicate worsening.
    Change From Baseline in Personal and Social Performance Scale (PSP) at Week 13
    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).
    Quality of Sleep Score
    This self-administered scale rates quality of sleep and daytime drowsiness. Participants indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time). On the sleep evaluation scale, score 0 corresponds to very badly and score 10 to very well.
    Daytime Drowsiness Evaluation Scale
    This self-administered scale rates quality of sleep and daytime drowsiness. Participants will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).On the daytime drowsiness scale, score 0 corresponds to not at all and score 10 to all the time.
    Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
    Extra pyramidal symptoms attributed to antipsychotic assessed by ESRS scale. Included 4 subscales; Parkinsonism (Park),dystonia(Dyst),dyskinesia(Dysk),akathisia(Akat),12 items on 4-point scale; (0=absent-3=severe); Park (8 items); Dyst (2 items); Dysk (7 items) all 3 rated on 7-point scale (0=none/normal-6=worst). Additionally, subtotals were calculated; hyperkinesia (item 5, 6 of Park); hypokinesia (item 1-4, 7 of Park); bucco-linguo-masticatory (item 1-3 of Dysk), choreoathetoid movement (item 5, 6 of Dysk). Total score: sum of Park, Dyst & Dysk subscale, ranged from 0 (normal)-102 (severe).

    Full Information

    First Posted
    May 26, 2011
    Last Updated
    April 29, 2013
    Sponsor
    Janssen-Cilag S.p.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01362439
    Brief Title
    Paliperidone Extended Release in Schizophrenia Participants With Duration of Illness Less Than 10 Years
    Official Title
    Efficacy and Tolerability of Flexible Doses of Paliperidone ER in Symptomatic Subjects With Schizophrenia With Duration of Illness < 10 Years
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    March 2010 (Actual)
    Study Completion Date
    March 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Janssen-Cilag S.p.A.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) in symptomatic participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were receiving treatment with any oral (having to do with the mouth) antipsychotic medication and who needed to be switched to paliperidone ER from the current oral antipsychotic therapy due to insufficient efficacy or due to side effects.
    Detailed Description
    This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center) and non-comparative study of paliperidone ER in participants with schizophrenia who have a previous history of bad adherence to the antipsychotic treatment because of insufficient efficacy and side-effects. All the eligible participants will receive a dose of paliperidone ER in range of 3 to 12 milligram (mg) orally (taken by mouth; to be swallowed) once daily for 13 weeks. Efficacy and safety will primarily be evaluated by Positive and Negative Syndromes Scale (PANSS) and Extrapyramidal Symptom Rating Scale (ESRS), respectively. Participants' safety will 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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Paliperidone ER
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Paliperidone ER
    Intervention Description
    Participants will be administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose will be increased or decreased as per Investigator's discretion.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 13
    Description
    The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) 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 and ranges from 30 to 210, higher scores indicate worsening.
    Time Frame
    Baseline and Week 13
    Secondary Outcome Measure Information:
    Title
    Change in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 13
    Description
    The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
    Time Frame
    Baseline and Week 13
    Title
    Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 13
    Description
    The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
    Time Frame
    Baseline and Week 13
    Title
    Change in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 13
    Description
    The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).
    Time Frame
    Baseline and Week 13
    Title
    Percentage of Participants With Greater Than or Equal to 30 Percent Treatment Response in Total Positive and Negative Syndrome Scale (PANSS) Score
    Description
    The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) 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 and ranges from 30 to 210, higher scores indicate worsening.
    Time Frame
    Baseline and Week 13
    Title
    Change From Baseline in Subjective Well-being Under Neuroleptic (SWN 20) Scale at Week 13
    Description
    The SWN 20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood.
    Time Frame
    Baseline and Week 13
    Title
    Change From Baseline in Drug Attitude Inventory (DAI 30) Scale at Week 13
    Description
    The DAI is a 30-item self-rating inventory that focuses on subjective effects of neuroleptic medications in participants with schizophrenia. There are 15 items that are scored as true and 15 scored as false if the person is fully compliant (positive subjective response). Positive answers score as +1, negative answers score as - 1. Questionnaire allows identifying participants at high risk of low compliance. The total score may vary from -30 to +30 with a high total final score is a positive subjective response (compliant) and a low total score is a negative subjective response (non-compliant).
    Time Frame
    Baseline and Week 13
    Title
    Clinical Global Impression-Severity Scale (CGI-S)
    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 participant. 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 participants. Higher scores indicate worsening.
    Time Frame
    Baseline and Week 13
    Title
    Change From Baseline in Personal and Social Performance Scale (PSP) at Week 13
    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 and Week 13
    Title
    Quality of Sleep Score
    Description
    This self-administered scale rates quality of sleep and daytime drowsiness. Participants indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time). On the sleep evaluation scale, score 0 corresponds to very badly and score 10 to very well.
    Time Frame
    Baseline and Week 13
    Title
    Daytime Drowsiness Evaluation Scale
    Description
    This self-administered scale rates quality of sleep and daytime drowsiness. Participants will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).On the daytime drowsiness scale, score 0 corresponds to not at all and score 10 to all the time.
    Time Frame
    Baseline and Week 13
    Title
    Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores
    Description
    Extra pyramidal symptoms attributed to antipsychotic assessed by ESRS scale. Included 4 subscales; Parkinsonism (Park),dystonia(Dyst),dyskinesia(Dysk),akathisia(Akat),12 items on 4-point scale; (0=absent-3=severe); Park (8 items); Dyst (2 items); Dysk (7 items) all 3 rated on 7-point scale (0=none/normal-6=worst). Additionally, subtotals were calculated; hyperkinesia (item 5, 6 of Park); hypokinesia (item 1-4, 7 of Park); bucco-linguo-masticatory (item 1-3 of Dysk), choreoathetoid movement (item 5, 6 of Dysk). Total score: sum of Park, Dyst & Dysk subscale, ranged from 0 (normal)-102 (severe).
    Time Frame
    Baseline and Week 13

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants meet the Diagnostic and Statistical Manual of Mental Disorders Fourth 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) Positive and Negative Syndrome Scale (PANSS) total score at Baseline of greater than equal to 70 and less than equal to 100 Participants who need to be switched from the current oral antipsychotic therapy because of lack of efficacy or side effects Participants followed as outpatients Female participants must be postmenopausal for at least 1 year, surgically sterile or, if sexually active, be practicing an effective method of birth control and female participants of childbearing potential must also have a negative urine pregnancy test at Baseline Exclusion Criteria: Acute psychotic relapse that requires hospitalization and first antipsychotic treatment ever Participants who had received clozapine during the previous 3 months History or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body) and neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness) Pregnant or breast-feeding female Participated in an investigational drug trial in the previous 30 days
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen-Cilag S.p.A. Italy Clinical Trial
    Organizational Affiliation
    Janssen-Cilag S.p.A.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Paliperidone Extended Release in Schizophrenia Participants With Duration of Illness Less Than 10 Years

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