A Phase 3 interventional study of Paliperidone ER in Schizophrenia, sponsored by Janssen Pharmaceutica. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-10-22.
Sponsored by Janssen Pharmaceutica (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
The purpose of this study is to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.
This is a single arm (the same intervention is given to all patients), multicenter study that aimed to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among Filipino patients with schizophrenia who have not taken any antipsychotics in the past, and among newly diagnosed schizophrenia patients who have not taken any antipsychotics for at least one month prior to screening. Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Flexible dosing allows the investigators to adjust the dosage of each patient based on the individual needs.
3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.
This study's enrollment of 188 is above the median of 70 across 2,924 interventional studies indexed under Schizophrenia.
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Exclusion Criteria:
Drug: Paliperidone ER
Type= range, unit= mg/day, number= 3 to 12, form= tablet, route= oral use. Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90)
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Time frame: Baseline, Day 90
Positive and Negative Syndrome Scale (PANSS) Scores at Baseline
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Time frame: Baseline
Positive and Negative Syndrome Scale (PANSS) Scores at Day 90
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Time frame: Day 90
Clinical Global Impression-Severity (CGIS) Scores at Baseline
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 patient. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)".
Time frame: Baseline
Clinical Global Impression-Severity (CGIS) Scores at Day 90
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 patient. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)".
Time frame: Day 90
Personal and Social Performance (PSP) Scores at Baseline
This PSP assesses the degree of a patient'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 (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients 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.
Time frame: Baseline
Personal and Social Performance (PSP) Scores at Day 90
This PSP assesses the degree of a patient'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 (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients 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.
Time frame: Day 90
Patient Satisfaction With Paliperidone Treatment
Patients will be interviewed to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor).
Time frame: 90 days
Quality of Sleep at Baseline
The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).
Time frame: Baseline
Quality of Sleep at Day 90
The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).
Time frame: Day 90
Daytime Drowsiness at Baseline
The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).
Time frame: Baseline
Daytime Drowsiness at Day 90
The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).
Time frame: Day 90
| Milestone | Paliperidone Extended-release (ER) |
|---|---|
| Started | 188 |
| Completed | 159 |
| Not completed | 29 |
| Withdrew: Lost to follow-up | 20 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Non-compliant | 3 |
| Withdrew: Lack of efficacy | 2 |
| Withdrew: Adverse event | 1 |
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
| percentage of patients | Paliperidone Extended-release (ER) |
|---|---|
| The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90) | 97.73 |
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
| scores on a scale | Paliperidone Extended-release (ER) |
|---|---|
| Positive and Negative Syndrome Scale (PANSS) Scores at Baseline | 108.25 ± 23.897 |
The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
| scores on a scale | Paliperidone Extended-release (ER) |
|---|---|
| Positive and Negative Syndrome Scale (PANSS) Scores at Day 90 | 48.74 ± 18.371 |
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 patient. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)".
| participants | Paliperidone Extended-release (ER) |
|---|---|
| Normal | 0 |
| Borderline | 0 |
| Mild | 0 |
| Moderate | 11 |
| Marked | 33 |
| Severe | 14 |
| Extreme | 2 |
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 patient. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)".
| participants | Paliperidone Extended-release (ER) |
|---|---|
| Normal | 0 |
| Borderline | 31 |
| Mild | 20 |
| Moderate | 8 |
| Marked | 1 |
| Severe | 0 |
| Extreme | 0 |
This PSP assesses the degree of a patient'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 (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients 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.
| scores on a scale | Paliperidone Extended-release (ER) |
|---|---|
| Personal and Social Performance (PSP) Scores at Baseline | 37.23 ± 12.675 |
This PSP assesses the degree of a patient'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 (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients 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.
| scores on a scale | Paliperidone Extended-release (ER) |
|---|---|
| Personal and Social Performance (PSP) Scores at Day 90 | 75.66 ± 10.451 |
Patients will be interviewed to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor).
| participants | Paliperidone Extended-release (ER) |
|---|---|
| Very good | 33 |
| Good | 34 |
| Moderate | 4 |
| Poor | 1 |
| Very poor | 1 |
The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).
| scores on a scale | Paliperidone Extended-release (ER) |
|---|---|
| Quality of Sleep at Baseline | 33.99 ± 30.091 |
The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).
| scores on a scale | Paliperidone Extended-release (ER) |
|---|---|
| Quality of Sleep at Day 90 | 86.56 ± 18.684 |
The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).
| scores on a scale | Paliperidone Extended-release (ER) |
|---|---|
| Daytime Drowsiness at Baseline | 21.49 ± 22.511 |
The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).
| scores on a scale | Paliperidone Extended-release (ER) |
|---|---|
| Daytime Drowsiness at Day 90 | 11.23 ± 19.061 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paliperidone Extended-release (ER) | — | 4/188 (2.1%) | 43/188 (22.9%) |
| Event | Paliperidone Extended-release (ER) |
|---|---|
| SchizophreniaPsychiatric disorders | 2/188 |
| Schizophrenia paranoid typePsychiatric disorders | 1/188 |
| ArrhythmiaCardiac disorders | 1/188 |
| Ventricular ExtrasystolesCardiac disorders | 1/188 |
| AkathisiaNervous system disorders | 1/188 |
| Event | Paliperidone Extended-release (ER) |
|---|---|
| InsomniaPsychiatric disorders | 25/188 |
| AnemiaMetabolism and nutrition disorders | 9/188 |
| HypertensionVascular disorders | 3/188 |
| PyrexiaGeneral disorders | 3/188 |
| Extra-Pyramidal SymptomsNervous system disorders | 3/188 |
| AkathisiaNervous system disorders | 3/188 |
| Acute psychotic symptomsPsychiatric disorders | 3/188 |
| Poor appetiteMetabolism and nutrition disorders | 3/188 |
| Disturbed behaviorPsychiatric disorders | 3/188 |
| SialorrheaGastrointestinal disorders | 3/188 |
| Age Continuous(years) | Paliperidone Extended-release (ER) |
|---|---|
| Mean | 33.71 ± 9.743 |
| Sex: Female, Male(Participants) | Paliperidone Extended-release (ER) |
|---|---|
| Female | 70 |
| Male | 106 |
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This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Paliperidone