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| ID | Type | Description | Link |
|---|---|---|---|
| R076477-SCH-3035 |
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The purpose of this study is to evaluate the effectiveness of paliperidone extended-release (ER; designed to slowly release a drug in the body over an extended period of time) tablets in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions [a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into the self) who were not satisfied with other prior antipsychotics (agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect; olanzapine, quetiapine and risperidone) they had been taking. The safety and tolerability of paliperidone ER tablets will also be assessed.
This is an open label (all people know the identity of the intervention), prospective (study following participants forward in time), non-randomized (the study drug is not assigned by chance, participants may choose which group they want to be in, or they may be assigned to the groups by the researchers), single-arm (getting one dose of medicine) and multi-center (when more than one hospital or medical school team work on a medical research study) study designed to determine the efficacy, tolerability and safety of flexible dosage of paliperidone ER tablets in treatment of participants with schizophrenia not satisfied with other prior antipsychotics. The duration of the study will be 12 weeks. All participants will be given paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator's discretion once daily for 12 weeks; initial dose for paliperidone ER will be 6 mg/day. The primary objective will be to evaluate the efficacy of treatment with paliperidone ER using Positive and Negative Symptom Scale (PANSS) total scores. Participants safety and tolerability 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 | Paliperidone Extended Release (ER) 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator's discretion once daily for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 | PANSS is a medical scale that assesses various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions [a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into the self). The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 12 | PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Positive syndrome subscale ranges from 7 to 49, higher change scores indicate worsening. Negative syndrome subscale ranges from 7 to 49, higher change scores indicate worsening. General Psychopathology subscale ranges from 16 to112, higher change scores indicate worsening. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xian-Janssen Pharmaceutical Ltd., China Clinical Trial | Xian-Janssen Pharmaceutical Ltd. | Study Director |
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405 participants were enrolled, out of which 403 participants were recruited in Safety Analysis Set (randomized and took at least 1 dose of study drug) and 394 subjects were included in full analysis set (had at least 1 efficacy evaluation).
Participants were recruited from 19 study centers between 30 July 2008 and 23 September 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paliperidone Extended Release (ER) | Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator's discretion once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paliperidone Extended Release (ER) | Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator's discretion once daily for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Information for demographics (age) was missing for 2 participants. |
| 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 12 | PANSS is a medical scale that assesses various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions [a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into the self). The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). | Full analysis set (FAS) included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. | Posted | Mean | Standard Deviation | unit on a scale | Baseline and Week 12 |
|
Baseline up to Week 12
An undesirable or unwanted consequence that occurs during the course of the clinical trial, but not necessarily because of study drug.
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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 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator's discretion once daily for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA Version13.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Manager | CDMA, Beijing | 00861058218352 |
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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 and Week 12 |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12 | 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). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28. Higher change score indicates greater severity. | Baseline and Week 12 |
| Percentage of Participants With Response to Positive and Negative Syndrome Scale (PANSS) Total Score | PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Percentage of participants with at least 20 percent improvement of PANSS total score was measured. | Week 12 |
| Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12 | 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 change scores indicate worsening. | Baseline and Week 12 |
| Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12 | PSP assesses the degree of a participant's dysfunction 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 (1, absent to 6, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants 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. | Baseline and Week 12 |
| Number of Participants With Satisfaction With the Study Treatment | Participants assessed their satisfaction with paliperidone ER on a 5-point scale: 1 (very good), 2 (good), 3 (moderate), 4 (poor) and 5 (very poor). | Baseline and Week 12 |
| Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Week 12 | The self-administered sleep VAS scale (0-100 milimeter [mm]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time). | Baseline and Week 12 |
| Lack of Efficacy |
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| Protocol Violation |
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| Study medication non-compliance |
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| Other |
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| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Paliperidone extended release (ER) tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
| OG001 | Lack of Tolerability Group | Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication). |
| OG002 | Other Group | Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator's discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons. |
|
|
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 12 | PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Positive syndrome subscale ranges from 7 to 49, higher change scores indicate worsening. Negative syndrome subscale ranges from 7 to 49, higher change scores indicate worsening. General Psychopathology subscale ranges from 16 to112, higher change scores indicate worsening. | FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12 | 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). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28. Higher change score indicates greater severity. | FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Percentage of Participants With Response to Positive and Negative Syndrome Scale (PANSS) Total Score | PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Percentage of participants with at least 20 percent improvement of PANSS total score was measured. | FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
|
|
|
| Secondary | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12 | 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 change scores indicate worsening. | FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here "N" (Number of Participants Analyzed): number of participants who were evaluable for this measure. 'n': number of participants who were evaluable at given time point for each arm group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12 | PSP assesses the degree of a participant's dysfunction 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 (1, absent to 6, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants 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. | FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here 'n': number of participants who were evaluable at given time point for each arm group, respectively. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Number of Participants With Satisfaction With the Study Treatment | Participants assessed their satisfaction with paliperidone ER on a 5-point scale: 1 (very good), 2 (good), 3 (moderate), 4 (poor) and 5 (very poor). | FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here "N" (Number of Participants Analyzed): number of participants who were evaluable for this measure. 'n': number of participants who were evaluable at given time point for each arm group, respectively. | Posted | Number | Participants | Baseline and Week 12 |
|
|
|
| Secondary | Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Week 12 | The self-administered sleep VAS scale (0-100 milimeter [mm]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time). | FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here "N" (Number of Participants Analyzed): number of participants who were evaluable for this measure. 'n': number of participants who were evaluable at given time point for each arm group, respectively. | Posted | Mean | Standard Deviation | mm | Baseline and Week 12 |
|
|
|
| 1 |
| 403 |
| 227 |
| 403 |
| Vomiting | Gastrointestinal disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Salivary hypersecretion | Gastrointestinal disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version13.0 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA Version13.0 | Non-systematic Assessment |
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| Transaminases increased | Investigations | MedDRA Version13.0 | Non-systematic Assessment |
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| Blood prolactin increased | Investigations | MedDRA Version13.0 | Non-systematic Assessment |
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| Obesity | Metabolism and nutrition disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Dystonia | Nervous system disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Extrapyramidal disorder | Nervous system disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Akathisia | Psychiatric disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Somnolence | Psychiatric disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| Menstrual disorders | Reproductive system and breast disorders | MedDRA Version13.0 | Non-systematic Assessment |
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| D011743 |
| Pyrimidines |
| Title | Measurements |
|---|---|
|
| Negative: Change at Week 12 |
|
| General psychopathology: Baseline |
|
| General psychopathology: Change at Week 12 |
|
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| Negative symptoms: Change at Week 12 |
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| Disorganized thoughts: Baseline |
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| Disorganized thoughts: Change at Week 12 |
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| Uncontrolled hostility/excitement: Baseline |
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| Uncontrolled hostility/excitement:Change at Week12 |
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| Anxiety/depression: Baseline |
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| Anxiety/depression: Change at Week 12 |
|
|
|
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| Baseline, Generally satisfied (n=230,113,41) |
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| Baseline, Dissatisfied (n=230,113,41) |
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| Baseline, Very dissatisfied (n=230,113,41) |
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| Week 12, Very satisfied (n=208,105,40) |
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| Week 12, Satisfied (n=208,105,40) |
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| Week 12, Generally satisfied (n=208,105,40) |
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| Week 12, Dissatisfied (n=208,105,40) |
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| Week 12, Very dissatisfied (n=208,105,40) |
|
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| Daytime drowsiness score: Baseline (n=233,115,41) |
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| Daytime drowsiness:Change at Week 12(n=202,106,40) |
|