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| ID | Type | Description | Link |
|---|---|---|---|
| R092670PSY3008 |
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The purpose of this study is to compare the efficacy of paliperidone palmitate and risperidone long acting injection (LAI) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) along with safety and tolerability.
This is a randomized (assigned by chance), open-label (all people know the identity of the intervention), active-controlled, parallel-group (a medical research study comparing the response in two or more groups of participants receiving different treatments), multicenter (when more than one hospital or medical school team work on a medical research study) comparative study in participants with schizophrenia. This study comprises a screening period of not more than 7 days and a 13-week open-label treatment period. Paliperidone palmitate will be administered as intramuscular injection (injection of a substance into a muscle) of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. at Day 8, flexible dose on Day 36 (50 or 100 mg eq.) and on Day 64 (50, 100 or 150 mg eq.) depending on investigator's discretion. Risperidone LAI will be administered at a dose of 25 mg at Day 8 and Day 22, flexible dose on Day 36 (25 or 37.5 mg) and Day 64 (25, 37.5, or 50 mg). Dose on Day 50 is the same as Day 36 and dose on Day 78 is the same as Day 64. Participants will receive oral risperidone tablets (1 to 6 mg/day) for the first 4 weeks of the open-label treatment period. Each participant may receive oral risperidone tablets (1 to 2 mg daily) for up to 3 weeks at Day 36 and Day 64 if the dose of risperidone LAI was increased on Day 36 and Day 64. Efficacy will primarily be assessed using the Positive and Negative Syndrome Scale (PANSS). Participants' safety will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paliperidone palmitate | Experimental | Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion. |
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| Risperidone long acting injection (LAI) | Active Comparator | Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone palmitate (R092670) | Drug | Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal | The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme psychopathology). Higher change scores indicate worsening. | Baseline, Day 92 or early withdrawal |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Personal and Social Performance (PSP) Score at Day 92 or Early Withdrawal | This 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 4, 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. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xian-Janssen Pharmaceutical Ltd. Clinical Trial | Xian-Janssen Pharmaceutical Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baoding | China | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Paliperidone Palmitate | Paliperidone palmitate (R092670) suspension for intramuscular (directly into a muscle) injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Risperidone | Drug | Risperidone LAI intramuscular at a dose of 25 mg on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64. |
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| Baseline, Day 92 or early withdrawal |
| Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 92 or Early Withdrawal | 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, Day 92 or early withdrawal |
| Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal | The self-administered sleep VAS scale (0-100 millimeter [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, Day 92 or early withdrawal |
| Percentage of Participants Who Responded to PANSS Total Score at Day 92 or Early Withdrawal | A responder is defined as a participant who improved from baseline in the PANSS total score by 30 percent or more. | Day 92 or early withdrawal |
| Beijing |
| China |
| Guangzhou | China |
| Hangzhou | China |
| Nanjing | China |
| Shanghai | China |
| Wuhan | China |
| Xi'an | China |
| Risperidone Long Acting Injection (LAI) |
Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paliperidone Palmitate | Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion. |
| BG001 | Risperidone Long Acting Injection (LAI) | Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| 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 | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Age Categorical | Number | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal | The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme psychopathology). Higher change scores indicate worsening. | Per Protocol Analysis Set included participants who received at least 2 injections of study medication had minimum 5 weeks of exposure to study treatment; had baseline and at least 1 post randomization measurement for primary efficacy variable and who did not have major protocol violations. | Posted | Mean | Standard Deviation | Units on scale | Baseline, Day 92 or early withdrawal |
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| Secondary | Change From Baseline in Personal and Social Performance (PSP) Score at Day 92 or Early Withdrawal | This 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 4, 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. | Per Protocol Analysis Set. Here "N" (Number of Participants Analyzed) represents number of participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | Units on scale | Baseline, Day 92 or early withdrawal |
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| Secondary | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 92 or Early Withdrawal | 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. | Per Protocol Analysis Set. Here "N" (Number of Participants Analyzed) represents number of participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | Units on scale | Baseline, Day 92 or early withdrawal |
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| Secondary | Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal | The self-administered sleep VAS scale (0-100 millimeter [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). | Per Protocol Analysis Set. | Posted | Mean | Standard Deviation | millimeter (mm) | Baseline, Day 92 or early withdrawal |
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| Secondary | Percentage of Participants Who Responded to PANSS Total Score at Day 92 or Early Withdrawal | A responder is defined as a participant who improved from baseline in the PANSS total score by 30 percent or more. | Per Protocol Analysis Set. | Posted | Number | Percentage of participants | Day 92 or early withdrawal |
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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 Palmitate | Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion. | 3 | 229 | 115 | 229 | ||
| EG001 | Risperidone Long Acting Injection (LAI) | Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64. | 8 | 223 | 127 | 223 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA Version 12.0 | Non-systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA Version 12.0 | Non-systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA Version 12.0 | Non-systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Completed suicide | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Psychiatric symptom | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Refusal of treatment by patient | Social circumstances | MedDRA Version 12.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
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| Blood prolactin increased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Bradykinesia | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Restlessness | Psychiatric disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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The disclosure restriction on the PI is that the sponsor can review results communications prior to publication and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The paper that incorporates confidential information requires Sponsor's written consent. PI will withhold publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Local Trial Manager | Xian-Janssen Pharmaceutical Ltd | 86-10-5821 8213 |
| 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 |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D011744 | Pyrimidinones |
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| Male |
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| 26-50 Years |
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| 51-65 Years |
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| >65 Years |
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| <18 Years |
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