Back to resultsA Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Paliperidone ER
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Paliperidone Extended Release (ER)
Eligibility Criteria
Inclusion Criteria:
- Participants who are diagnosed with schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders [Edition 4] criteria)
- Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening
- Childbearing potential women who consented to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
- Participants who are capable of and willing to fill out the questionnaire for themselves
- Participants who are compliant with self-medication or can receive consistent help or support
Exclusion Criteria:
- Participants with the past 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 allergy or hypersensitivity to risperidone or paliperidone
- Participants who have taken clozapine, or have been exposed to the study drug within one month before screening
- Participants who have been treated with the long acting antipsychotic injection within 28 days
- Participants with significant risk including suicide or aggressive behavior
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 Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Responders were defined as participants evaluated as "1: very much improved" or "2: much improved" on the CGI-I scale at Week 12.
Secondary Outcome Measures
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12
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.
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Change From Baseline in Personal and Social Performance (PSP) Score at Week 12
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).
Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12
The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response (SR). A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive SR; a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
Full Information
NCT ID
NCT01577160
First Posted
April 12, 2012
Last Updated
November 25, 2013
Sponsor
Johnson & Johnson Taiwan Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01577160
Brief Title
A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia
Official Title
An Open Label, Prospective, Non-Comparative Study to Evaluate Flexible Dose of Paliperidone ER and Clinical Response in the Treatment of Subjects With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 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 evaluate the effectiveness of paliperidone ER for the treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.
Detailed Description
This is a multi-center (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following participants forward in time), non-comparative study. The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 2, 4, 8, and 12 (end of treatment or early withdrawal). The effectiveness of paliperidone ER will be evaluated at Week 12 by the proportion of responders who are evaluated as "very much improved" or "much improved" on the Clinical Global Impression improvement (CGI-I) 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 (ER)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
353 (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 6 milligram (mg) orally once daily up to Week 12. Dose adjustment will be done at Week 2, 4 and 8 as per investigator's discretion based upon participant's CGI-I score.
Primary Outcome Measure Information:
Title
Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale
Description
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Responders were defined as participants evaluated as "1: very much improved" or "2: much improved" on the CGI-I scale at Week 12.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12
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, Week 12
Title
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
Description
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time Frame
Week 12
Title
Change From Baseline in 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
Title
Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12
Description
The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response (SR). A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive SR; a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
Time Frame
Baseline, Week 12
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:
Participants who are diagnosed with schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders [Edition 4] criteria)
Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening
Childbearing potential women who consented to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
Participants who are capable of and willing to fill out the questionnaire for themselves
Participants who are compliant with self-medication or can receive consistent help or support
Exclusion Criteria:
Participants with the past 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 allergy or hypersensitivity to risperidone or paliperidone
Participants who have taken clozapine, or have been exposed to the study drug within one month before screening
Participants who have been treated with the long acting antipsychotic injection within 28 days
Participants with significant risk including suicide or aggressive behavior
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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A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia
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