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| ID | Type | Description | Link |
|---|---|---|---|
| R076477SCH4033 |
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The purpose of the study is to explore the maintained efficacy, tolerability, and safety of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) previously unsuccessfully treated with other oral atypical antipsychotic medication.
This is an open-label (all people know the identity of the intervention), non-randomized (the study drug is not assigned by chance), single arm, multicenter (when more than one hospital or medical school team work on a medical research study), 24-week study. Participants can be transitioned to an effective dose of paliperidone ER from any oral antipsychotic medication without the need for titration due to lack of efficacy, lack of tolerability or safety, lack of compliance or other reason. A transition period of maximum 4 weeks will be allowed. Throughout the study, participants will receive flexible dose of 3 to 12 milligram (mg) of paliperidone once daily orally for 24 weeks. Dose adjustment will be done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug. Assessments of efficacy will be performed at screening and after 2, 4, 12 and 24 weeks. Efficacy will primarily be evaluated by means of Positive and Negative Syndrome Scale (PANSS). Participants' safety will also be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paliperidone Extended-Release (ER) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone ER | Drug | Participants will receive paliperidone ER tablet in dose range of 3 to12 milligram (mg) per day orally once daily for 24 weeks as per Investigator's discretion based on the individual participant's clinical response to and tolerability of the study drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24 | The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 24 | The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Marder PANSS subscales include positive symptoms subscale consisting of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consisting of 7 items with total score range of 7-49; and uncontrolled hostility/excitement (UH/E) subscale and anxiety/depression subscale, each consisting of 4 items with total score range of 4-28. Higher score indicates greater severity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Taiwan, Ltd. Clinical Trial | Johnson & Johnson Taiwan Ltd | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paliperidone Extended Release (ER) | Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paliperidone Extended Release (ER) | Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug. |
| 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 | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24 | The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. | Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using last observation carried forward (LOCF). Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 24 |
|
Baseline up to Week 24
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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) | Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA Version | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA Version | Non-systematic Assessment |
Some Adverse Events summaries were reported based on estimates due to the fact that they were not prepared in the original study report and the relevant definitions of the data elements were not available for these summaries to be regenerated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Janssen Research & Development | 886 2 23762155 |
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| 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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|
| Baseline, Week 24 |
| Percentage of Participants With at Least 20 Percent Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score | The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. | Up to Week 24 |
| Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24 | 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). | Baseline, Week 24 |
| Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 24 | 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. | Baseline, Week 24 |
| Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 24 | 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". | Baseline, Week 24 |
| Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Week 24 | The SF-36 is a health status survey with 36 questions measuring 8 dimensions (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are subsequently aggregated into 2 summary scales, Physical Component Summary (PCS) and Mental Component Summary (MCS). Each item is scored into on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. | Baseline, Week 24 |
| Number of Participants With Satisfaction With the Study Treatment | Participants assessed their satisfaction with paliperidone ER on a 5-point scale (very good, good, moderate, poor or very poor). | Week 24 |
| Change From Baseline in Sleep Quality and Daytime Drowsiness Score at Week 24 | The Sleep Quality and Daytime Drowsiness evaluation scale is a self-administered scale that rates quality of sleep and daytime drowsiness. Participants indicated on a 5 point scale how well they have slept in the previous 7 days, score ranging from 1 (very badly) to 5 (very well) and how often they have felt drowsy within the previous 7 days, score ranging from 1 (not at all) to 5 (all the time). | Baseline, Week 24 |
| Insufficient Response |
|
| Ineligible to continue |
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| Non-compliant |
|
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| Paliperidone Extended Release (ER) |
Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug. |
|
|
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 24 | The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Marder PANSS subscales include positive symptoms subscale consisting of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consisting of 7 items with total score range of 7-49; and uncontrolled hostility/excitement (UH/E) subscale and anxiety/depression subscale, each consisting of 4 items with total score range of 4-28. Higher score indicates greater severity. | ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 24 |
|
|
|
| Secondary | Percentage of Participants With at Least 20 Percent Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score | The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. | ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies participants evaluable for this measure. | Posted | Number | Percentage of participants | Up to Week 24 |
|
|
|
| Secondary | Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24 | 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). | ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 24 |
|
|
|
| Secondary | Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 24 | 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. | ITT population: all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at specified time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 24 |
|
|
|
| Secondary | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 24 | 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". | ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 24 |
|
|
|
| Secondary | Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Week 24 | The SF-36 is a health status survey with 36 questions measuring 8 dimensions (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are subsequently aggregated into 2 summary scales, Physical Component Summary (PCS) and Mental Component Summary (MCS). Each item is scored into on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. | ITT population: all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at specified time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 24 |
|
|
|
| Secondary | Number of Participants With Satisfaction With the Study Treatment | Participants assessed their satisfaction with paliperidone ER on a 5-point scale (very good, good, moderate, poor or very poor). | ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies participants evaluable for this measure. | Posted | Number | Participants | Week 24 |
|
|
|
| Secondary | Change From Baseline in Sleep Quality and Daytime Drowsiness Score at Week 24 | The Sleep Quality and Daytime Drowsiness evaluation scale is a self-administered scale that rates quality of sleep and daytime drowsiness. Participants indicated on a 5 point scale how well they have slept in the previous 7 days, score ranging from 1 (very badly) to 5 (very well) and how often they have felt drowsy within the previous 7 days, score ranging from 1 (not at all) to 5 (all the time). | ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 24 |
|
|
|
| 11 |
| 299 |
| 180 |
| 299 |
| Fall | Injury, poisoning and procedural complications | MedDRA Version | Non-systematic Assessment |
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| Blood Electrolytes Abnormal | Investigations | MedDRA Version | Non-systematic Assessment |
|
| Hepatic Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version | Non-systematic Assessment |
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| Haemorrhage Intracranial | Nervous system disorders | MedDRA Version | Non-systematic Assessment |
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| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version | Non-systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA Version | Non-systematic Assessment |
|
| Hallucination, Auditory | Psychiatric disorders | MedDRA Version | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version | Non-systematic Assessment |
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| Psychotic Disorder | Psychiatric disorders | MedDRA Version | Non-systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA Version | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA Version | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA Version | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version | Non-systematic Assessment |
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| Muscle Rigidity | Musculoskeletal and connective tissue disorders | MedDRA Version | Non-systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA Version | Non-systematic Assessment |
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| Bradykinesia | Nervous system disorders | MedDRA Version | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version | Non-systematic Assessment |
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| Extrapyramidal Disorder | Nervous system disorders | MedDRA Version | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version | Non-systematic Assessment |
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| Parkinsonism | Nervous system disorders | MedDRA Version | Non-systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA Version | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA Version | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA Version | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA Version | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Version | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Version | Non-systematic Assessment |
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| Hallucination, Auditory | Psychiatric disorders | MedDRA Version | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version | Non-systematic Assessment |
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| Panic Disorder | Psychiatric disorders | MedDRA Version | Non-systematic Assessment |
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| Sleep Disorder | Psychiatric disorders | MedDRA Version | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version | Non-systematic Assessment |
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| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA Version | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version | Non-systematic Assessment |
|
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| D011743 |
| Pyrimidines |
|
| Negative symptoms:Change at Week 24 (n=281) |
|
| Disorganized thoughts: Baseline (n=297) |
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| Disorganized thoughts: Change at Week 24 (n=281) |
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| UH/E: Baseline (n=297) |
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| UH/E: Change at Week 24 (n=281) |
|
| Anxiety/depression: Baseline (n=297) |
|
| Anxiety/depression:Change at Week 24(n=281) |
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| Title | Measurements |
|---|---|
|
| MCS: Change at Week 24 (n=228) |
|
| Title | Measurements |
|---|
|
| Poor |
|
| Very poor |
|
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| Daytime drowsiness:Change at Week 24 (n=278) |
|