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| ID | Type | Description | Link |
|---|---|---|---|
| R076477PSZ3002 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia.
This is a 6-month, open-label study (the patient, investigator, and sponsor know the study drug and dosage being taken by the patient) of the safety and tolerability of flexible-dose (1.5 to 12mg per day), extended-release (ER) paliperidone in adolescents with a diagnosis of schizophrenia. Patients who have completed study R076477PSZ3001 or who discontinued from that study because of lack of efficacy but completed a minimum of 21 days of the study may enter this study. Patients may also enter this study directly without participating in R076477PSZ3001. This study consists of a 21-day screening and washout phase (to discontinue and "wash out" any medication not allowed in the study), an open-label treatment phase of up to 26 weeks during which all patients will take oral paliperidone ER every day, and a post-treatment phase consisting of a follow-up visit completed 1 week after a patient has received the final dose of paliperidone ER. The study, including the screening and posttreatment phase, will last approximately 30 weeks. Screening and washout may be conducted while a patient is either an inpatient or an outpatient. Safety will be assessed by laboratory measurements (chemistry, liver function tests, hematology, hormone, lipid assessments, prolactin [blinded], urinalysis, and urine drug screens); body weight, height, and waist circumference measurements; ECGs; and physical examinations (including Tanner staging). The Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Rating Scale (SAS) will be used to assess extrapyramidal symptoms (EPS) and dyskinesias. Adverse events will be monitored including psychiatric adverse events of interest (i.e., suicide and related phenomena, homicidal ideation, depressed mood, and worsening of psychosis) that may be associated with paliperidone ER in this population. The primary aim of this study is to evaluate the long-term (6-month) safety and tolerability of paliperidone ER in adolescents with schizophrenia. As exploratory secondary aims, the study will assess the effect of paliperidone ER on the long-term symptoms of schizophrenia as measured by the changes in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores, the global improvement in severity of illness as measured by the Clinical Global Impression-Severity (CGI-S) scale, the benefits in psychological, social, and school functioning as measured by the Children's Global Assessment Scale (CGAS), the changes in multiple domains of cognitive functioning measured by the modified Measurements and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) assessment battery, and the effect on sleep as measured by the sleep Visual Analog Scale (VAS). Patients begin the study at 6.0 mg/day of oral paliperidone ER. If a higher dosage is needed, the dosage will be increased (in increments of 3 mg/day not more frequently than once every 5 days) to 12 mg/day. If the 6.0 mg/day dosage is not well tolerated, the dosage may be decreased (not more frequently than once every 5 days) to 3.0 mg/day or 1.5 mg/day. Patients will be dosed for up to 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | Paliperidone ER1.5 to 12 mg tablet once daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone ER | Drug | 1.5 to 12 mg tablet once daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability | A serious adverse event as defined by the International Conference on Harmonisation (ICH) is any untoward medical occurrence that at any dose results in death, is life-threatening (the subject was at risk of death at the time of the even; it does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Open-label Baseline to Open-label Endpoint in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Scores - Last Observation Carried Forward | The 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cerritos | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28660406 | Derived | Gopal S, Lane R, Nuamah I, Copenhaver M, Singh J, Hough D, Bach M, Savitz A. Evaluation of Potentially Prolactin-Related Adverse Events and Sexual Maturation in Adolescents with Schizophrenia Treated with Paliperidone Extended-Release (ER) for 2 Years: A Post Hoc Analysis of an Open-Label Multicenter Study. CNS Drugs. 2017 Sep;31(9):797-808. doi: 10.1007/s40263-017-0437-9. |
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Patients enrolled in this study came from 3 different sources: patients who enrolled directly, patients who were randomly assigned to placebo in the R076477PSZ3001 (NCT00518323) study, and patients who were randomly assigned to paliperidone ER in the R076477PSZ3001 (NCT00518323) study.
This study evaluated the long-term (2 year) safety and tolerability of paliperidone extended release (ER) in adolescent patients with schizophrenia. This study was conducted from 27 June 2007 to 18 July 2012 at 55 centers in 10 countries. A total of 400 patients received at least 1 dose of the study drug and were included in the safety analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Paliperidone | Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline, Week 104 or the last post-baseline assessment |
| Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - Last Observation Carried Forward | Neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale. PANSS scale provides a total score (sum of scores of all 30 items) and scores for 3 subscales, ie, positive (7 items), negative (7 items), and general psychopathology (16 items) subscales. Each item is scored on a scale of 1 (absent) to 7 (extreme). Positive Factor Score (range: 8 to 56): sum of select scores from positive, negative, and general psychopathology subscales. Negative Factor Score (range: 7 to 49): sum of select scores from negative and general psychopathology subscales. Disorganized Thoughts Factor Score (range: 7 to 49): sum of select scores from positive, negative, and general psychopathology subscales. Uncontrolled Hostility/Excitement Factor Score (range: 4 to 28): sum of select scores from positive and general psychopathology subscales. Anxiety/Depression Factor Score (range: 4 to 28): sum of select scores from general psychopathology subscale. Higher scores indicate worsening. | Baseline, Week 104 or the last post-baseline assessment |
| Change From Open-label Baseline to Open-label Endpoint in the Clinical Global Impression Severity (CGI-S) Scale - Last Observation Carried Forward | 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, Week 104 or the last post-baseline assessment |
| Change From Open-label Baseline to Open-label Endpoint in the Children's Global Assessment Scale (CGAS) - Last Observation Carried Forward | The CGAS is a 100 point rating scale which measures the psychological, social, and school functioning for children 6 to 17 years of age. The score ranges from 1 to 100, divided into 10 equal intervals to rate the impairment level of general functioning (poor to superior functioning). Higher scores denote better functioning. | Baseline, Week 104 or the last post-baseline assessment |
| Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Motor Speed Domain Test Variable, Finger Tapping Dominant- and Non-Dominant Hand, Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | Baseline, Week 24 |
| Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Coding, Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | Baseline, Week 24 |
| Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Digit Span, Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | Baseline, Week 24 |
| Change From Open-label Baseline to Open-label - Cognitive Domain: Verbal Learning and Memory Domain Test Variable Wide Range Assessment of Memory and Learning Story - Total, Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | Baseline, Week 24 |
| Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Verbal Learning and Memory Domain Test Variable California Verbal Learning Test-Total Trials, Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | Baseline, Week 24 |
| Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Visual Learning and Memory Domain Test Variable, Rey Complex Figure Test - Total, Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | Baseline, Week 24 |
| Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Social Cognition Domain Test Variable - Theory of Mind-Total - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | Baseline, Week 24 |
| Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Trials Part A Time: Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | Baseline, Week 24 |
| Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Child Color Trials Test 1 Time: Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | Baseline, Week 24 |
| Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Phonetic Verbal Fluency: Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | Baseline, Week 24 |
| Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Semantic Verbal Fluency, Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | Baseline, Week 24 |
| Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable, Trials Part B Time, Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | Baseline, Week 24 |
| Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable - Wisconsin Card Sort Test-Total Errors: Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | Baseline, Week 24 |
| Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Quality of Sleep - Last Observation Carried Forward | Sleep VAS is a self administered scale that rates the quality of sleep and daytime drowsiness. Participants make a mark on a line to represent how well they have slept in the previous 7 days ("very badly" to "very well") and how often they have felt drowsy within the previous 7 days ("not at all" to "all the time"). The score for each item ranges from 0 to 100 mm. For quality of sleep, a score of 0 indicates "Very badly" and a score of 100 indicates "Very well." For daytime drowsiness, a score of 0 indicates "Not at all" and a score of 100 indicates "All the time." Improvement of the condition is indicated by the positive change for the quality of sleep and the negative change for the daytime drowsiness. | Baseline, Week 104 or the last post-baseline assessment |
| Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Daytime Drowsiness - Last Observation Carried Forward | Sleep VAS is a self administered scale that rates the quality of sleep and daytime drowsiness. Participants make a mark on a line to represent how well they have slept in the previous 7 days ("very badly" to "very well") and how often they have felt drowsy within the previous 7 days ("not at all" to "all the time"). The score for each item ranges from 0 to 100 mm. For quality of sleep, a score of 0 indicates "Very badly" and a score of 100 indicates "Very well." For daytime drowsiness, a score of 0 indicates "Not at all" and a score of 100 indicates "All the time." Improvement of the condition is indicated by the positive change for the quality of sleep and the negative change for the daytime drowsiness. | Baseline, Week 104 or the last post-baseline assessment |
| San Diego |
| California |
| United States |
| Santa Ana | California | United States |
| Middletown | Connecticut | United States |
| Washington D.C. | District of Columbia | United States |
| Jacksonville | Florida | United States |
| Coeur d'Alene | Idaho | United States |
| Chicago | Illinois | United States |
| Lake Charles | Louisiana | United States |
| Shreveport | Louisiana | United States |
| Las Vegas | Nevada | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Antwerp | Belgium |
| Sofia | Bulgaria |
| Tallinn | Estonia |
| Tartu | Estonia |
| Viljandi | Estonia |
| Hus | Finland |
| Kellokoski | Finland |
| Chennai | India |
| Hyderabad | India |
| Mangalore | India |
| Varanasi | India |
| Gdansk | Poland |
| Lódź | Poland |
| Poznan | Poland |
| Sosnowiec | Poland |
| Torun | Poland |
| Warsaw | Poland |
| Bucharest | Romania |
| Ekaterinburg Na | Russia |
| Kazan' | Russia |
| Moscow | Russia |
| Moscow Russia | Russia |
| Nizhny Novgorod | Russia |
| Saint Petersburg | Russia |
| Saratov | Russia |
| Smolensk Region N/A | Russia |
| Stavropol Na | Russia |
| Tomsk Na | Russia |
| Yaroslavl | Russia |
| Cheonan | South Korea |
| Gyeonggi-do | South Korea |
| Kyunggi-Do | South Korea |
| Seoul | South Korea |
| Dnipro | Ukraine |
| Hlevakha | Ukraine |
| Kharkiv | Ukraine |
| Kiev | Ukraine |
| Odesa | Ukraine |
| Simferopol | Ukraine |
| FG001 | Paliperidone (Double-blind)/Paliperidone | Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| FG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Paliperidone | Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| BG001 | Paliperidone (Double-blind)/Paliperidone | Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| BG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | 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 | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability | A serious adverse event as defined by the International Conference on Harmonisation (ICH) is any untoward medical occurrence that at any dose results in death, is life-threatening (the subject was at risk of death at the time of the even; it does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. | The safety analysis set was used for the safety analyses and included all enrolled participants who received at least 1 dose of the open-label study drug as recorded on the electronic case report form. This population was considered as evaluable participants. | Posted | Number | Number of Participants | Up to 2 years |
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| Secondary | Change From Open-label Baseline to Open-label Endpoint in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Scores - Last Observation Carried Forward | The 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). | The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 104 or the last post-baseline assessment |
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| Secondary | Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - Last Observation Carried Forward | Neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale. PANSS scale provides a total score (sum of scores of all 30 items) and scores for 3 subscales, ie, positive (7 items), negative (7 items), and general psychopathology (16 items) subscales. Each item is scored on a scale of 1 (absent) to 7 (extreme). Positive Factor Score (range: 8 to 56): sum of select scores from positive, negative, and general psychopathology subscales. Negative Factor Score (range: 7 to 49): sum of select scores from negative and general psychopathology subscales. Disorganized Thoughts Factor Score (range: 7 to 49): sum of select scores from positive, negative, and general psychopathology subscales. Uncontrolled Hostility/Excitement Factor Score (range: 4 to 28): sum of select scores from positive and general psychopathology subscales. Anxiety/Depression Factor Score (range: 4 to 28): sum of select scores from general psychopathology subscale. Higher scores indicate worsening. | The open label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open label study drug and had both the baseline and at least 1 postbaseline assessment in the open label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 104 or the last post-baseline assessment |
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| Secondary | Change From Open-label Baseline to Open-label Endpoint in the Clinical Global Impression Severity (CGI-S) Scale - Last Observation Carried Forward | 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 open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set. | Posted | Median | Full Range | Scores on a scale | Baseline, Week 104 or the last post-baseline assessment |
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| Secondary | Change From Open-label Baseline to Open-label Endpoint in the Children's Global Assessment Scale (CGAS) - Last Observation Carried Forward | The CGAS is a 100 point rating scale which measures the psychological, social, and school functioning for children 6 to 17 years of age. The score ranges from 1 to 100, divided into 10 equal intervals to rate the impairment level of general functioning (poor to superior functioning). Higher scores denote better functioning. | The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 104 or the last post-baseline assessment |
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| Secondary | Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Motor Speed Domain Test Variable, Finger Tapping Dominant- and Non-Dominant Hand, Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 24 |
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| Secondary | Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Coding, Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 24 |
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| Secondary | Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Digit Span, Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Open-label Baseline to Open-label - Cognitive Domain: Verbal Learning and Memory Domain Test Variable Wide Range Assessment of Memory and Learning Story - Total, Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Verbal Learning and Memory Domain Test Variable California Verbal Learning Test-Total Trials, Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Visual Learning and Memory Domain Test Variable, Rey Complex Figure Test - Total, Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Social Cognition Domain Test Variable - Theory of Mind-Total - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | The open label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open label study drug and had both the baseline and at least 1 postbaseline assessment in the open label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Trials Part A Time: Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | The open label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open label study drug and had both the baseline and at least 1 postbaseline assessment in the open label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Child Color Trials Test 1 Time: Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Phonetic Verbal Fluency: Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Semantic Verbal Fluency, Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable, Trials Part B Time, Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable - Wisconsin Card Sort Test-Total Errors: Scaled - Last Observation Carried Forward | A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance. | The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Quality of Sleep - Last Observation Carried Forward | Sleep VAS is a self administered scale that rates the quality of sleep and daytime drowsiness. Participants make a mark on a line to represent how well they have slept in the previous 7 days ("very badly" to "very well") and how often they have felt drowsy within the previous 7 days ("not at all" to "all the time"). The score for each item ranges from 0 to 100 mm. For quality of sleep, a score of 0 indicates "Very badly" and a score of 100 indicates "Very well." For daytime drowsiness, a score of 0 indicates "Not at all" and a score of 100 indicates "All the time." Improvement of the condition is indicated by the positive change for the quality of sleep and the negative change for the daytime drowsiness. | The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 104 or the last post-baseline assessment |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Daytime Drowsiness - Last Observation Carried Forward | Sleep VAS is a self administered scale that rates the quality of sleep and daytime drowsiness. Participants make a mark on a line to represent how well they have slept in the previous 7 days ("very badly" to "very well") and how often they have felt drowsy within the previous 7 days ("not at all" to "all the time"). The score for each item ranges from 0 to 100 mm. For quality of sleep, a score of 0 indicates "Very badly" and a score of 100 indicates "Very well." For daytime drowsiness, a score of 0 indicates "Not at all" and a score of 100 indicates "All the time." Improvement of the condition is indicated by the positive change for the quality of sleep and the negative change for the daytime drowsiness. | The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 104 or the last post-baseline assessment |
|
Up to 2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo/Paliperidone | Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. | 9 | 39 | 26 | 39 | ||
| EG001 | Paliperidone (Double-blind)/Paliperidone | Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. | 4 | 118 | 74 | 118 | ||
| EG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. | 46 | 243 | 192 | 243 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | 15.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | 15.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | 15.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 15.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | 15.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | 15.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | 15.0 | Non-systematic Assessment |
| |
| Frostbite | Injury, poisoning and procedural complications | 15.0 | Non-systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | 15.0 | Non-systematic Assessment |
| |
| Upper Limb Fracture | Injury, poisoning and procedural complications | 15.0 | Non-systematic Assessment |
| |
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | 15.0 | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | 15.0 | Non-systematic Assessment |
| |
| Dystonia | Nervous system disorders | 15.0 | Non-systematic Assessment |
| |
| Hypokinesia | Nervous system disorders | 15.0 | Non-systematic Assessment |
| |
| Oromandibular Dystonia | Nervous system disorders | 15.0 | Non-systematic Assessment |
| |
| Speech Disorder | Nervous system disorders | 15.0 | Non-systematic Assessment |
| |
| Adjustment Disorder | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Delusion | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Delusion of Grandeur | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Depressed Mood | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Depressive Symptom | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Flight of Ideas | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Hallucination, Auditory | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Intentional Self-Injury | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Mania | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Oppositional Defiant Disorder | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Paranoia | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Schizophrenia, Paranoid Type | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Schizophrenia, Undifferentiated Type | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Self Injurious Behaviour | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Tension | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 15.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | 15.0 | Non-systematic Assessment |
| |
| Ingrowing Nail | Skin and subcutaneous tissue disorders | 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | 15.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 15.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | 15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 15.0 | Non-systematic Assessment |
| |
| Salivary Hypersecretion | Gastrointestinal disorders | 15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 15.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | 15.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | 15.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 15.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | 15.0 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | 15.0 | Non-systematic Assessment |
| |
| Increased Appetite | Metabolism and nutrition disorders | 15.0 | Non-systematic Assessment |
| |
| Muscle Rigidity | Musculoskeletal and connective tissue disorders | 15.0 | Non-systematic Assessment |
| |
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | 15.0 | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | 15.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | 15.0 | Non-systematic Assessment |
| |
| Dystonia | Nervous system disorders | 15.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | 15.0 | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | 15.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | 15.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | 15.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | 15.0 | Non-systematic Assessment |
| |
| Galactorrhoea | Reproductive system and breast disorders | 15.0 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | 15.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | 15.0 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. Expedited reviews will be arranged for abstracts, poster presentations, or other materials. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Research | Johnson & Johnson Research & Development, LLC | 1-609-730-6771 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068882 | Paliperidone Palmitate |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Estonia |
|
| Finland |
|
| India |
|
| Korea |
|
| Poland |
|
| Romania |
|
| Russia |
|
| Ukraine |
|
| United States of America |
|
| Possibly-related TEAEs |
|
| One or More Serious TEAEs |
|
Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
| OG001 | Paliperidone (Double-blind)/Paliperidone | Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
| OG001 |
| Paliperidone (Double-blind)/Paliperidone |
Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
| Paliperidone (Double-blind)/Paliperidone |
Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
| Paliperidone (Double-blind)/Paliperidone |
Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
| OG001 | Paliperidone (Double-blind)/Paliperidone | Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
| OG001 |
| Paliperidone (Double-blind)/Paliperidone |
Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
| OG001 |
| Paliperidone (Double-blind)/Paliperidone |
Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
| Paliperidone (Double-blind)/Paliperidone |
Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
| OG001 |
| Paliperidone (Double-blind)/Paliperidone |
Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
| OG001 |
| Paliperidone (Double-blind)/Paliperidone |
Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
| OG001 |
| Paliperidone (Double-blind)/Paliperidone |
Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
| OG001 |
| Paliperidone (Double-blind)/Paliperidone |
Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
| OG001 | Paliperidone (Double-blind)/Paliperidone | Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
| OG001 | Paliperidone (Double-blind)/Paliperidone | Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
| OG001 | Paliperidone (Double-blind)/Paliperidone | Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|
| OG001 | Paliperidone (Double-blind)/Paliperidone | Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG002 | Paliperidone (No Double-blind)/Paliperidone | Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated. |
| OG003 | Total |
|
|