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| ID | Type | Description | Link |
|---|---|---|---|
| R076477SCH3037 | |||
| 2008-002384-13 |
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The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) in symptomatic participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were receiving treatment with any oral (having to do with the mouth) antipsychotic medication and who needed to be switched to paliperidone ER from the current oral antipsychotic therapy due to insufficient efficacy or due to side effects.
This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center) and non-comparative study of paliperidone ER in participants with schizophrenia who have a previous history of bad adherence to the antipsychotic treatment because of insufficient efficacy and side-effects. All the eligible participants will receive a dose of paliperidone ER in range of 3 to 12 milligram (mg) orally (taken by mouth; to be swallowed) once daily for 13 weeks. Efficacy and safety will primarily be evaluated by Positive and Negative Syndromes Scale (PANSS) and Extrapyramidal Symptom Rating Scale (ESRS), respectively. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paliperidone ER | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone ER | Drug | Participants will be administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose will be increased or decreased as per Investigator's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 13 | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening. | Baseline and Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 13 | The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). | Baseline and Week 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag S.p.A. Italy Clinical Trial | Janssen-Cilag S.p.A. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paliperidone ER | Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paliperidone ER | Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Out of a total of 133 participants, Baseline characteristic (Age) was available for only 132 participants who were included in intent to treat (ITT) population. |
| 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 13 | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening. | Intent to Treat Population (ITT) included all participants who received at least 1 dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using Last observation carried forward (LOCF) method.' N' (number of participants analyzed): participants evaluable for this measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 13 |
|
Baseline up to end of study (Week 13)
Safety population included all participants who receive at least one dose of study medication (n=132).
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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 ER | Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of Schizophrenia | Nervous system disorders | MedDRA/ V10.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypopiesia | Cardiac disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Medical Manager | Janssen-Cilag SpA, Cologno Monzese, Milan - Italy | +39 0225101 |
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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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|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 13 | The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). | Baseline and Week 13 |
| Change in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 13 | The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology). | Baseline and Week 13 |
| Percentage of Participants With Greater Than or Equal to 30 Percent Treatment Response in Total Positive and Negative Syndrome Scale (PANSS) Score | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening. | Baseline and Week 13 |
| Change From Baseline in Subjective Well-being Under Neuroleptic (SWN 20) Scale at Week 13 | The SWN 20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. | Baseline and Week 13 |
| Change From Baseline in Drug Attitude Inventory (DAI 30) Scale at Week 13 | The DAI is a 30-item self-rating inventory that focuses on subjective effects of neuroleptic medications in participants with schizophrenia. There are 15 items that are scored as true and 15 scored as false if the person is fully compliant (positive subjective response). Positive answers score as +1, negative answers score as - 1. Questionnaire allows identifying participants at high risk of low compliance. The total score may vary from -30 to +30 with a high total final score is a positive subjective response (compliant) and a low total score is a negative subjective response (non-compliant). | Baseline and Week 13 |
| Clinical Global Impression-Severity Scale (CGI-S) | 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. | Baseline and Week 13 |
| Change From Baseline in Personal and Social Performance Scale (PSP) at Week 13 | 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 and Week 13 |
| Quality of Sleep Score | This self-administered scale rates quality of sleep and daytime drowsiness. Participants indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time). On the sleep evaluation scale, score 0 corresponds to very badly and score 10 to very well. | Baseline and Week 13 |
| Daytime Drowsiness Evaluation Scale | This self-administered scale rates quality of sleep and daytime drowsiness. Participants will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).On the daytime drowsiness scale, score 0 corresponds to not at all and score 10 to all the time. | Baseline and Week 13 |
| Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores | Extra pyramidal symptoms attributed to antipsychotic assessed by ESRS scale. Included 4 subscales; Parkinsonism (Park),dystonia(Dyst),dyskinesia(Dysk),akathisia(Akat),12 items on 4-point scale; (0=absent-3=severe); Park (8 items); Dyst (2 items); Dysk (7 items) all 3 rated on 7-point scale (0=none/normal-6=worst). Additionally, subtotals were calculated; hyperkinesia (item 5, 6 of Park); hypokinesia (item 1-4, 7 of Park); bucco-linguo-masticatory (item 1-3 of Dysk), choreoathetoid movement (item 5, 6 of Dysk). Total score: sum of Park, Dyst & Dysk subscale, ranged from 0 (normal)-102 (severe). | Baseline and Week 13 |
| Study medication non-compliant |
|
| Participant who withdrew consent |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Out of a total of 133 participants, Baseline characteristic (Gender) was available for only 132 participants who were included in ITT population. | Count of Participants | Participants |
|
| OG000 | Paliperidone ER | Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion. |
|
|
| Secondary | Change in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 13 | The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). | The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 13 |
|
|
|
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 13 | The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). | The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 13 |
|
|
|
| Secondary | Change in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 13 | The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology). | The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 13 |
|
|
|
| Secondary | Percentage of Participants With Greater Than or Equal to 30 Percent Treatment Response in Total Positive and Negative Syndrome Scale (PANSS) Score | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening. | The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method. 'N' (number of participants analyzed) signified participants evaluable for this measure. | Posted | Number | percentage of participants | Baseline and Week 13 |
|
|
|
| Secondary | Change From Baseline in Subjective Well-being Under Neuroleptic (SWN 20) Scale at Week 13 | The SWN 20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. | The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 13 |
|
|
|
| Secondary | Change From Baseline in Drug Attitude Inventory (DAI 30) Scale at Week 13 | The DAI is a 30-item self-rating inventory that focuses on subjective effects of neuroleptic medications in participants with schizophrenia. There are 15 items that are scored as true and 15 scored as false if the person is fully compliant (positive subjective response). Positive answers score as +1, negative answers score as - 1. Questionnaire allows identifying participants at high risk of low compliance. The total score may vary from -30 to +30 with a high total final score is a positive subjective response (compliant) and a low total score is a negative subjective response (non-compliant). | The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 13 |
|
|
|
| Secondary | Clinical Global Impression-Severity Scale (CGI-S) | 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. | The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post Baseline was used for final evaluation using LOCF method. | Posted | Median | Full Range | units on a scale | Baseline and Week 13 |
|
|
|
| Secondary | Change From Baseline in Personal and Social Performance Scale (PSP) at Week 13 | 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). | The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post Baseline was used for final evaluation using LOCF method. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 13 |
|
|
|
| Secondary | Quality of Sleep Score | This self-administered scale rates quality of sleep and daytime drowsiness. Participants indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time). On the sleep evaluation scale, score 0 corresponds to very badly and score 10 to very well. | The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 13 |
|
|
|
| Secondary | Daytime Drowsiness Evaluation Scale | This self-administered scale rates quality of sleep and daytime drowsiness. Participants will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).On the daytime drowsiness scale, score 0 corresponds to not at all and score 10 to all the time. | ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 13 |
|
|
|
| Secondary | Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores | Extra pyramidal symptoms attributed to antipsychotic assessed by ESRS scale. Included 4 subscales; Parkinsonism (Park),dystonia(Dyst),dyskinesia(Dysk),akathisia(Akat),12 items on 4-point scale; (0=absent-3=severe); Park (8 items); Dyst (2 items); Dysk (7 items) all 3 rated on 7-point scale (0=none/normal-6=worst). Additionally, subtotals were calculated; hyperkinesia (item 5, 6 of Park); hypokinesia (item 1-4, 7 of Park); bucco-linguo-masticatory (item 1-3 of Dysk), choreoathetoid movement (item 5, 6 of Dysk). Total score: sum of Park, Dyst & Dysk subscale, ranged from 0 (normal)-102 (severe). | Safety population included all participants who received atleast one dose of study medication. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 13 |
|
|
|
| 1 |
| 132 |
| 21 |
| 132 |
| Increased Blood Pressure | Cardiac disorders | MedDRA/ V10.1 | Non-systematic Assessment |
|
| Tachicardia | Cardiac disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Rash (Mycosis) | Skin and subcutaneous tissue disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Galactorrhoea | Endocrine disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Weight Increase | Metabolism and nutrition disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Agitation | Nervous system disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Insomnia | Nervous system disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Akatisia | Nervous system disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Anxiety | Nervous system disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Extrapyramidal Symptoms | Nervous system disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Increased Anxiety | Nervous system disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Increased Irritability | Nervous system disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Jaw Movements | Nervous system disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Lingual Movements | Nervous system disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Lower Limbs Tremor | Nervous system disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Psychomotor Agitation | Nervous system disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Ptyalism | Nervous system disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Slowness (Increased) | Nervous system disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Worsening of Anxiety | Nervous system disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Worsening of Bradikinesia | Nervous system disorders | MedDRA/ V10.1 | Non-systematic Assessment |
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| Worsening of Tremor | Nervous system disorders | MedDRA/ V10.1 | Non-systematic Assessment |
|
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| D011743 |
| Pyrimidines |
| Title | Measurements |
|---|---|
|
| Week 13: Park, Dyst, Dysk and Akat |
|
| Baseline: Park |
|
| Week 13: Park |
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| Baseline: Dyst |
|
| Week 13: Dyst |
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| Baseline: Dysk Movements |
|
| Week 13: Dysk Movements |
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| Baseline: Hyperkinesia |
|
| Week 13: Hyperkinesia |
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| Baseline: Hypokinesia |
|
| Week 13: Hypokinesia |
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| Baseline: Bucco-Linguo-Masticatory |
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| Week 13: Bucco-Linguo-Masticatory |
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| Baseline: Choreoathetoid movements of limbs |
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| Week 13: Choreoathetoid movements of limbs |
|