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| ID | Type | Description | Link |
|---|---|---|---|
| R076477SCH3021 |
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The purpose of this trial is to evaluate the dose distribution, effectiveness and safety in patients with schizophrenia who are switched from an oral atypical antipsychotic to Paliperidone ER. In this study patients and physicians know the name and the dose of the study drug. Newly diagnosed patients will also be included in the study. In general, the recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can be adjusted any point during the study, to a maximum dose of 12mg/day. Flexible dosing was chosen to best mimic actual clinical practice.The safety assessments to be conducted throughout this study including the regular monitoring and recording of all Adverse Events and Serious Adverse Events.
This trial is a non-randomised (both patient and physician know the study drug), single arm, open label multicentre study which is aimed to evaluate the dose distribution, efficacy and safety in patients with schizophrenia who are switched from an oral atypical antipsychotic to Paliperidone ER. Newly diagnosed patients will also be included in the study. In general, the recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can be adjusted any point during the study, to a maximum dose of 12mg/day. Flexible dosing was chosen to best mimic actual clinical practice.The study duration will be split into two phases. Phase A will be 12 weeks and Phase B which will be an optional follow up phase will be 40 weeks. Assessment of efficacy and safety will be performed in Phase A at baseline, 2, 4, 6, 9 and 12 weeks and in Phase B at 20, 28, 36, 44 and 52 weeks. At the first visit, a full psychiatric history, demographic data and physical examination will be undertaken. Throughout the study, the following procedures, documentations and evaluations will be performed: descriptions of concomitant medications; hospitalisations for psychiatric reasons; clinical deterioration; Clinical Global Impression - Severity (CGI-S) and Global Assessment of Functioning (GAF) assessments; Community Treatment Order (CTO) status; weight; adherence and adverse event reporting. Physical examinations will be performed periodically. Paliperidone ER OROS will be supplied in 3 mg, 6 mg, and 9 mg tablets for oral administration. In general, the recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can be adjusted any point during the study, to a maximum dose of 12mg/day. The study duration will be split into two phases. Phase A will be 12 weeks and Phase B which will be an optional follow up phase
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | Paliperidone3mg or 6mg or 9mg or 12mg once daily for 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone | Drug | 3mg or 6mg or 9mg or 12mg once daily for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84 | Day 1 to Day 84 | |
| The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84 | Day 1 to Day 84 | |
| The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84 | Day 57 to Day 84 | |
| The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84 | Day 57 to Day 84 | |
| The Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12 | Week 0 to Week 12 | |
| The Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12 | Week 0 to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The Clinical Global Impression of Severity (CGI-S) Throughout the Study | 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. 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 patients". | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Pty Ltd Clinical Trial | Janssen-Cilag Pty Ltd | Study Director |
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| Label | URL |
|---|---|
| An open label multicentre study to determine the dose distribution of Paliperidone ER OROS® in patients with schizophrenia | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paliperidone Extended Release (ER) | Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paliperidone Extended Release (ER) | Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84 | Intent-To-Treat (ITT) population | Posted | Jun 2012 | Mean | Standard Deviation | mg | Day 1 to Day 84 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paliperidone Extended Release (ER) | Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA SOC | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Cardiac disorders | MedDRA SOC | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regional Medical Affairs Therapeutic Lead Immunol | Jan-Cil Australia | 61 2 88753219 |
| 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 |
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| The Global Assessment of Functioning (GAF) Throughout the Study | The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death. | 52 Weeks |
| The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | This Outcome Measure is intended to document only the hospitalizations associated with clinical deterioration, ie, when the patient needs to be hospitalized due to exacerbation of psychotic symptoms. | 52 Weeks |
| The Number of Hospitalizations Throughout the Study | This outcome measure is intended to document all hospitalizations that occurred throughout the study. | 52 Weeks |
| The Length of Hospitalizations Throughout the Study | 52 weeks |
| Lack of Efficacy |
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| Adverse Event |
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| Patient was selling medication to others |
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| Safety evaluation |
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| Reason not specified |
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| Ceased in favor of Paliperidone |
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| Switching to trial medication |
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| No longer required |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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| Primary | The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84 | Intent-To-Treat (ITT) population | Posted | Jun 2012 | Median | 95% Confidence Interval | mg | Day 1 to Day 84 |
|
|
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| Primary | The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84 | Intent-To-Treat (ITT) population, excluding participants no longer participating in the study at Day 57 | Posted | Jun 2012 | Mean | Standard Deviation | mg | Day 57 to Day 84 |
|
|
|
| Primary | The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84 | Intent-To-Treat (ITT) population, excluding participants no longer participating in the study at Day 57 | Posted | Jun 2012 | Median | 95% Confidence Interval | mg | Day 57 to Day 84 |
|
|
|
| Primary | The Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12 | Intent-To-Treat (ITT) population | Posted | Jun 2012 | Mean | Standard Deviation | mg | Week 0 to Week 12 |
|
|
|
| Primary | The Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12 | Intent-To-Treat (ITT) population | Posted | Jun 2012 | Median | 95% Confidence Interval | mg | Week 0 to Week 12 |
|
|
|
| Secondary | The Clinical Global Impression of Severity (CGI-S) Throughout the Study | 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. 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 patients". | All participants with evaluable data at each measurement time point | Posted | Jun 2012 | Mean | Standard Deviation | scores on a scale | 52 weeks |
|
|
|
| Secondary | The Global Assessment of Functioning (GAF) Throughout the Study | The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death. | All participants with evaluable data at each measurement time point | Posted | Jun 2012 | Mean | Standard Deviation | scores on a scale | 52 Weeks |
|
|
|
| Secondary | The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | This Outcome Measure is intended to document only the hospitalizations associated with clinical deterioration, ie, when the patient needs to be hospitalized due to exacerbation of psychotic symptoms. | All participants with evaluable data at each measurement time point | Posted | Jun 2012 | Number | percentage of participants | 52 Weeks |
|
|
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| Secondary | The Number of Hospitalizations Throughout the Study | This outcome measure is intended to document all hospitalizations that occurred throughout the study. | All participants with evaluable data at each measurement time point | Posted | Jun 2012 | Number | events | 52 Weeks |
|
|
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| Secondary | The Length of Hospitalizations Throughout the Study | Participants who were hospitalized and had evaluable data at each measurement time point | Posted | Jun 2012 | Mean | Standard Deviation | days | 52 weeks |
|
|
|
| 27 |
| 64 |
| 51 |
| 64 |
| Lethargy | General disorders | MedDRA SOC | Non-systematic Assessment |
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| Encephalitis viral | Infections and infestations | MedDRA SOC | Non-systematic Assessment |
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| Intentional overdose | Injury, poisoning and procedural complications | MedDRA SOC | Non-systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA SOC | Non-systematic Assessment |
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| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA SOC | Non-systematic Assessment |
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| Dystonia | Nervous system disorders | MedDRA SOC | Non-systematic Assessment |
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| Extrapyramidal disorder | Nervous system disorders | MedDRA SOC | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA SOC | Non-systematic Assessment |
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| Hallucination, auditory | Psychiatric disorders | MedDRA SOC | Non-systematic Assessment |
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| Mental disorders | Psychiatric disorders | MedDRA SOC | Non-systematic Assessment |
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| Paranoia | Psychiatric disorders | MedDRA SOC | Non-systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA SOC | Non-systematic Assessment |
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| Schizoaffective disorder | Psychiatric disorders | MedDRA SOC | Non-systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA SOC | Non-systematic Assessment |
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| Schizophrenia exacerbated | Psychiatric disorders | MedDRA SOC | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA SOC | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA SOC | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA SOC | Non-systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA SOC | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA SOC | Non-systematic Assessment |
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| Vision blurred | Nervous system disorders | MedDRA SOC | Non-systematic Assessment |
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| Akathisia | Psychiatric disorders | MedDRA SOC | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA SOC | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA SOC | Non-systematic Assessment |
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| D011743 |
| Pyrimidines |
| Care Increase |
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| Suicidal |
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| Violent |
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| Self Injury |
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