Back to resultsA Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Paliperdidone ER
Aripiprazole, olanzapine and risperidone (Antipsychotics)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Paliperidone ER, Antipsychotics, Mental disorder, Comparative study
Eligibility Criteria
Inclusion Criteria:
- Must be diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
- Have taken atypical antipsychotics (aripiprazole, olanzapine, risperidone) at least 6 weeks prior to start of study.
- Have Medication Satisfaction Questionnaire (MSQ) score of ≤3
- Competent patients who manage to answer the questionnaires
Exclusion Criteria:
- Have had a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome
- Have had relevant history of or current presence of any significant or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic, morbid obesity (BMI≥40), or other systemic disease
- Had received two or more different kind of antipsychotics.
- Had a history of taking paliperidone extended release (ER).
- Allergy or hypersensitivity to risperidone or paliperidone ER.
- Have been on clozapine or long-acting injectable antipsychotic medication during the last 3 months.
- Have had Medication Satisfaction Questionnaire (MSQ) score>3
- Have been hospitalized for longer than 8 continuous weeks during the past 6 months
- Had history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or inability to swallow the oral tolerability medication whole with the aid of water for patients requiring oral tolerability testing
- Current substance dependence (DSM-IV) or past history of dependence (more than 6 months)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Paliperidone ER
Antipsychotics and paliperidone ER
Arm Description
Immediate initiation of Paliperidone ER for a total of 12 weeks
Delayed initiation included previous atypical antipsychotics for 8 weeks and then be initiated on paliperidone ER at Day 56 for 4 weeks. The atypical antipsychotics includes aripiprazole, olanzapine and risperidone. These antipsychotics belongs to the class of second generation bipolar atypical antipsychotics.
Outcomes
Primary Outcome Measures
Change From Baseline in the medication satisfaction questionnaire (MSQ) score at Week 8
A single-item, global, patient-completed instrument that is read aloud to patients by clinicians designed to assess treatment satisfaction among patients with schizophrenia. It consists of one question: "Overall, how satisfied are you with your current antipsychotic medication(s)?" with responses assessed on a 7-point scale rated as follows: 1 = extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6 = very satisfied, 7 = extremely satisfied
Secondary Outcome Measures
Positive and negative symptoms scale (PANSS) score
The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). It's designed to capture symptoms of schizophrenia. (Gold standard)
Drug Attitude Inventory (DAI)-10 Score
DAI-10 is a 10-item scale developed to assess how the attitude of schizophrenia patients toward their medications may affect compliance (-10~+10)
Clinical Global Impression-Severity (CGI-S) Score
The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe)
Personal and Social Performance Scale (PSP)
This scale assesses the degree of dysfunction a patient exhibits 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. Patient's 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
Sleep Visual Analog Scale (Sleep VAS)
This self-administered scale rates quality of sleep and daytime drowsiness. Patient's will indicate on an 11- point scale (from 0 to 10) how well they have slept in the previous 7 days ("very badly" to "very well") and how often they have felt drowsy within the previous 7 days ("not at all" to "all the time"). On the sleep evaluation scale, score '0' corresponds to 'very badly' and score '10' to 'very well'. On the daytime drowsiness scale, score '0' corresponds to 'not at all' and score '10' to 'all the time
Number of patients with adverse events
Number of patients with vital signs and physical examination
Number of patients with laboratory test (prolactin, blood glucose, glycosylated hemoglobin, cholesterol, triglyceride)
Full Information
NCT ID
NCT01592201
First Posted
February 10, 2012
Last Updated
June 24, 2014
Sponsor
Janssen Korea, Ltd., Korea
1. Study Identification
Unique Protocol Identification Number
NCT01592201
Brief Title
A Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug
Official Title
An Open-label, Prospective, Randomized and Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
This study was early terminated due to insufficient enrollment required for hypothesis testing.
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Korea, Ltd., Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the patient satisfaction between continued administration of previous antipsychotics versus switched administration to paliperidone ER in non-satisfied patients with previous (paliperidone)
Detailed Description
This is a randomized (patients are assigned to intervention by chance), prospective, open-label (all people involved know the identity of the assigned drug), switch study designed to evaluate patient-assessed medication satisfaction after 12 weeks of treatment in patients with schizophrenia. The total duration of this study is 12 weeks. Outpatients who treated atypical antipsychotics and report dissatisfaction (Medication Satisfaction Questionnaire [MSQ] <4) with their current treatment response are eligible to participate in the study. Patients will be randomized into two groups, 1) Patients randomized to an immediate initiation of paliperidone ER for a total 12 weeks 2) Patients randomized to a delayed initiation will continue their previous atypical antipsychotics for 8 weeks and then be initiated on paliperidone ER at Day 56 for 4 weeks. During the study treatment optimization will be done by dose adjustment (dose increase or decrease) and by adding psychotropic agents except the antipsychotics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Paliperidone ER, Antipsychotics, Mental disorder, Comparative study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paliperidone ER
Arm Type
Experimental
Arm Description
Immediate initiation of Paliperidone ER for a total of 12 weeks
Arm Title
Antipsychotics and paliperidone ER
Arm Type
Experimental
Arm Description
Delayed initiation included previous atypical antipsychotics for 8 weeks and then be initiated on paliperidone ER at Day 56 for 4 weeks. The atypical antipsychotics includes aripiprazole, olanzapine and risperidone. These antipsychotics belongs to the class of second generation bipolar atypical antipsychotics.
Intervention Type
Drug
Intervention Name(s)
Paliperdidone ER
Intervention Description
Form = osmotic release oral system, route = oral
Intervention Type
Drug
Intervention Name(s)
Aripiprazole, olanzapine and risperidone (Antipsychotics)
Intervention Description
Form = tablet, route = oral
Primary Outcome Measure Information:
Title
Change From Baseline in the medication satisfaction questionnaire (MSQ) score at Week 8
Description
A single-item, global, patient-completed instrument that is read aloud to patients by clinicians designed to assess treatment satisfaction among patients with schizophrenia. It consists of one question: "Overall, how satisfied are you with your current antipsychotic medication(s)?" with responses assessed on a 7-point scale rated as follows: 1 = extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6 = very satisfied, 7 = extremely satisfied
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Positive and negative symptoms scale (PANSS) score
Description
The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). It's designed to capture symptoms of schizophrenia. (Gold standard)
Time Frame
Baseline to Week 12
Title
Drug Attitude Inventory (DAI)-10 Score
Description
DAI-10 is a 10-item scale developed to assess how the attitude of schizophrenia patients toward their medications may affect compliance (-10~+10)
Time Frame
Baseline to Week 12
Title
Clinical Global Impression-Severity (CGI-S) Score
Description
The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe)
Time Frame
Baseline to Week 12
Title
Personal and Social Performance Scale (PSP)
Description
This scale assesses the degree of dysfunction a patient exhibits 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. Patient's 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 to Week 12
Title
Sleep Visual Analog Scale (Sleep VAS)
Description
This self-administered scale rates quality of sleep and daytime drowsiness. Patient's will indicate on an 11- point scale (from 0 to 10) how well they have slept in the previous 7 days ("very badly" to "very well") and how often they have felt drowsy within the previous 7 days ("not at all" to "all the time"). On the sleep evaluation scale, score '0' corresponds to 'very badly' and score '10' to 'very well'. On the daytime drowsiness scale, score '0' corresponds to 'not at all' and score '10' to 'all the time
Time Frame
Baseline to Week 12
Title
Number of patients with adverse events
Time Frame
Baseline to Week 12
Title
Number of patients with vital signs and physical examination
Time Frame
Baseline to Week 12
Title
Number of patients with laboratory test (prolactin, blood glucose, glycosylated hemoglobin, cholesterol, triglyceride)
Time Frame
Baseline to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
Have taken atypical antipsychotics (aripiprazole, olanzapine, risperidone) at least 6 weeks prior to start of study.
Have Medication Satisfaction Questionnaire (MSQ) score of ≤3
Competent patients who manage to answer the questionnaires
Exclusion Criteria:
Have had a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome
Have had relevant history of or current presence of any significant or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic, morbid obesity (BMI≥40), or other systemic disease
Had received two or more different kind of antipsychotics.
Had a history of taking paliperidone extended release (ER).
Allergy or hypersensitivity to risperidone or paliperidone ER.
Have been on clozapine or long-acting injectable antipsychotic medication during the last 3 months.
Have had Medication Satisfaction Questionnaire (MSQ) score>3
Have been hospitalized for longer than 8 continuous weeks during the past 6 months
Had history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or inability to swallow the oral tolerability medication whole with the aid of water for patients requiring oral tolerability testing
Current substance dependence (DSM-IV) or past history of dependence (more than 6 months)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Korea, Ltd., Korea Clinical Trial
Organizational Affiliation
Janssen Korea, Ltd., Korea
Official's Role
Study Director
Facility Information:
City
Busan
Country
Korea, Republic of
City
Cheonan City
Country
Korea, Republic of
City
Chuncheon-Si
Country
Korea, Republic of
City
Chungju-Si
Country
Korea, Republic of
City
Dae-Gu
Country
Korea, Republic of
City
Daejeon
Country
Korea, Republic of
City
Goyang-Si
Country
Korea, Republic of
City
Gyeonggi-Do
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3450&filename=CR100782_CSR.pdf
Description
A comparative study of patient satisfaction between continued administration of previous antipsychotics versus switched administration to paliperidone ER in non-satisfied patients with previous antipsychotic drug
Learn more about this trial
A Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug
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