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| ID | Type | Description | Link |
|---|---|---|---|
| R092670SCH4010 | Other Identifier | Janssen Korea, Ltd., Korea | |
| PALM-KOR-4001 | Other Identifier | Janssen Korea, Ltd., Korea |
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The purpose of this study is to evaluate the change of medication satisfaction measured by Medication Satisfaction Questionnaire (MSQ) from baseline to endpoint for patients who are switched into paliperidone palmitate, either immediately or in a delayed mode.
This is a prospective (patients are first identified and then followed forward as time passes), multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), comparative and open-labeled (all people know the identity of the intervention) study.
The study mainly consists of 3 phases including, the screening phase (14 days before administration of study medication), treatment phase, and the follow-up phase (28 days after the last dose of the study medication). In the treatment phase, patients will be randomly assigned equally in 2 groups (Group 1 and Group 2), on the basis of known and unknown characteristics. Group 1 (immediate switch group): Patients will be administered with paliperidone palmitate immediately after randomization and will continue throughout the treatment phase. Group 2 (delayed switch group): Patients will remain on current oral antipsychotics until Week 8, and later on will be completely switched to paliperidone palmitate. However, during the first 8 weeks if the symptoms or satisfaction with MSQ further deteriorates for Group 2, they may be switched into paliperidone palmitate earlier.
Safety evaluations will include evaluation of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination and these will be monitored throughout the study.
The total duration of the study will be approximately 148 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Immediate switch) | Experimental | Paliperidone palmitate will be administered immediately after randomization and will be continued throughout the treatment phase. |
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| Group 2 (Delayed switch) | Experimental | Current oral antipsychotics will be continued until Week 8, and later on paliperidone palmitate will be administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone palmitate | Drug | Paliperidone palmitate will be administrated in accordance with each product's information. Recommended initial loading doses are 150 mg equivalent on Day 1 and 100 mg equivalent on Day 8, followed by subsequent once-monthly administration with 75 mg equivalent or flexible dose between 25 mg and 150 mg equivalent. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 21 in scores of Medication Satisfaction Questionnaire (MSQ) | MSQ is designed to assess treatment satisfaction among patients with schizophrenia. The responses will be assessed on a 7-point Likert-type scale rated as follows: 1=extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6=very satisfied, and 7=extremely satisfied. | Screening (Week -2), baseline (Week 0), Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 21 in scores of Treatment Satisfaction Questionnaire for Medication (TSQM) | The TSQM is a 14-item subject assessed evaluation of treatment medication using a 7-point Likert-type 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. |
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Inclusion Criteria:- Meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders Version IV
Exclusion Criteria:
History of neuroleptic malignant syndrome
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buchun | South Korea | |||||
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| Label | URL |
|---|---|
| An open-label, comparative study of immediate or delayed switch to paliperidone palmitate in patients unsatisfied with current oral atypical antipsychotics to evaluate the evolution of medication satisfaction and adherence | View source |
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| Screening, baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21 |
| Change from baseline to Week 21 in scores of Positive and Negative Syndrome Scale (PANSS) | The PANSS is a medical scale used for measuring symptom severity of patients with schizophrenia. The neuropsychiatric symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item is rated as follows: 1=absent, 2=Minimal, 3=Mild, 4=Moderate, 5=Moderate Severe, 6=Severe, and 7=Extreme. | Baseline, Week 8, and Week 21 |
| Change from baseline to Week 21 in scores of Clinical Global Impression - Severity (CGI-S) scale | The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. | Baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21 |
| Change from baseline to Week 21 in scores of Personal and Social Performance (PSP) scale | The PSP is a clinician rated instrument providing an overall rating of personal and social functioning in patients with schizophrenia on a scale of 1-100. The scale defines a continuum from grossly impaired functioning, in which total lack of autonomy in basic functioning and survival risk is evident, to excellent functioning. Four domains of functioning are considered in the rating: 1) socially useful activities, including work and study, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. | Baseline, Week 8, and Week 21 |
| Score of Mediation Adherence Rating Scale (MARS) | The MARS is a 10-items self-rating scale to measure the adherence of the drug medication for psychosis. Each item is answered "yes/no" and the total score ranges from 0 points (Low medication adherence) to 10 points (High medication adherence). | Baseline |
| Cheonan |
| South Korea |
| Chungcheongbuk-Do | South Korea |
| Daegu | South Korea |
| Goyang | South Korea |
| Gyeonggi-do | South Korea |
| Incheon | South Korea |
| Seognam-Si, Kyungki-Do | South Korea |
| Seoul | South Korea |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068882 | Paliperidone Palmitate |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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