Schizophrenia
Conditions
Keywords
Schizophrenia, Paliperidone ER, Treatment naive patients, Newly diagnosed patients
Brief summary
The purpose of this study is to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.
Detailed description
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.
Interventions
DRUGPaliperidone 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.
Sponsors
Janssen Pharmaceutica
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with schizophrenia * Patient with Positive and Negative Syndrome Scale (PANSS) score of 80 to 120 at screening * Patients who have not taken any antipsychotics in the past, and those were newly diagnosed with schizophrenia who have not taken any antipsychotics for at least one month prior to screening * Patient healthy on the basis of a physical examination, laboratory examination, and vital signs * Women must have a negative pregnancy test, and agree to practice an effective method of birth control before entry and throughout the study
Exclusion criteria
* Serious unstable medical condition, including known clinically relevant laboratory abnormalities * Judged to be at high risk for adverse events, violence or self-harm * Inability to swallow the study medication whole with the aid of water (patients may not chew, divide, dissolve, or crush the study medication) * Biochemistry results that are out of the laboratory's normal reference range and are deemed to be clinically significant by the investigator * Patients with a current use or known history (over the past 6 months) of substance dependence * Positive urine drug examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90) | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) Scores at Day 90 | 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. |
| Clinical Global Impression-Severity (CGIS) Scores at Baseline | 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). |
| Clinical Global Impression-Severity (CGIS) Scores at Day 90 | 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). |
| Personal and Social Performance (PSP) Scores at Baseline | 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. |
| Personal and Social Performance (PSP) Scores at Day 90 | 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. |
| Positive and Negative Syndrome Scale (PANSS) Scores at Baseline | 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. |
| Quality of Sleep at Baseline | 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). |
| Quality of Sleep at Day 90 | 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). |
| Daytime Drowsiness at Baseline | 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). |
| Daytime Drowsiness at Day 90 | 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). |
| Patient Satisfaction With Paliperidone Treatment | 90 days | Patients will be interviewed to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor). |
Participant flow
Pre-assignment details
There were 188 patients enrolled in the study which were included in the safety analysis set. The main analysis set included only 176 subjects due to 12 protocol violations. Of these 176 patients, only 73 were included in the per-protocol analysis set. For the Clinical Global Impression-Severity scores, data was collected for only 60 patients.
Participants by arm
| Arm | Count |
|---|---|
| Paliperidone Extended-release (ER) 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. | 176 |
| Total | 176 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 20 |
| Overall Study | Non-compliant | 3 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Paliperidone Extended-release (ER) |
|---|---|
| Age Continuous | 33.71 years STANDARD_DEVIATION 9.743 |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 43 / 188 |
| serious Total, serious adverse events | 4 / 188 |
Outcome results
Primary
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
Population: Per Protocol (PP) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paliperidone Extended-release (ER) | The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90) | 97.73 percentage of patients |
Secondary
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
Population: Per Protocol (PP) population; participants for whom CGIS data was collected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Extended-release (ER) | Clinical Global Impression-Severity (CGIS) Scores at Baseline | Normal | 0 participants |
| Paliperidone Extended-release (ER) | Clinical Global Impression-Severity (CGIS) Scores at Baseline | Borderline | 0 participants |
| Paliperidone Extended-release (ER) | Clinical Global Impression-Severity (CGIS) Scores at Baseline | Mild | 0 participants |
| Paliperidone Extended-release (ER) | Clinical Global Impression-Severity (CGIS) Scores at Baseline | Moderate | 11 participants |
| Paliperidone Extended-release (ER) | Clinical Global Impression-Severity (CGIS) Scores at Baseline | Marked | 33 participants |
| Paliperidone Extended-release (ER) | Clinical Global Impression-Severity (CGIS) Scores at Baseline | Severe | 14 participants |
| Paliperidone Extended-release (ER) | Clinical Global Impression-Severity (CGIS) Scores at Baseline | Extreme | 2 participants |
Secondary
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
Population: Per Protocol (PP) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Extended-release (ER) | Clinical Global Impression-Severity (CGIS) Scores at Day 90 | Normal | 0 participants |
| Paliperidone Extended-release (ER) | Clinical Global Impression-Severity (CGIS) Scores at Day 90 | Borderline | 31 participants |
| Paliperidone Extended-release (ER) | Clinical Global Impression-Severity (CGIS) Scores at Day 90 | Mild | 20 participants |
| Paliperidone Extended-release (ER) | Clinical Global Impression-Severity (CGIS) Scores at Day 90 | Moderate | 8 participants |
| Paliperidone Extended-release (ER) | Clinical Global Impression-Severity (CGIS) Scores at Day 90 | Marked | 1 participants |
| Paliperidone Extended-release (ER) | Clinical Global Impression-Severity (CGIS) Scores at Day 90 | Severe | 0 participants |
| Paliperidone Extended-release (ER) | Clinical Global Impression-Severity (CGIS) Scores at Day 90 | Extreme | 0 participants |
Secondary
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
Population: Per Protocol (PP) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Extended-release (ER) | Daytime Drowsiness at Baseline | 21.49 scores on a scale | Standard Deviation 22.511 |
Secondary
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
Population: Per Protocol (PP) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Extended-release (ER) | Daytime Drowsiness at Day 90 | 11.23 scores on a scale | Standard Deviation 19.061 |
Secondary
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
Population: Per Protocol (PP) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Extended-release (ER) | Patient Satisfaction With Paliperidone Treatment | Very good | 33 participants |
| Paliperidone Extended-release (ER) | Patient Satisfaction With Paliperidone Treatment | Good | 34 participants |
| Paliperidone Extended-release (ER) | Patient Satisfaction With Paliperidone Treatment | Moderate | 4 participants |
| Paliperidone Extended-release (ER) | Patient Satisfaction With Paliperidone Treatment | Poor | 1 participants |
| Paliperidone Extended-release (ER) | Patient Satisfaction With Paliperidone Treatment | Very poor | 1 participants |
Secondary
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
Population: Per Protocol (PP) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Extended-release (ER) | Personal and Social Performance (PSP) Scores at Baseline | 37.23 scores on a scale | Standard Deviation 12.675 |
Secondary
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
Population: Per Protocol (PP) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Extended-release (ER) | Personal and Social Performance (PSP) Scores at Day 90 | 75.66 scores on a scale | Standard Deviation 10.451 |
Secondary
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
Population: Per Protocol (PP) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Extended-release (ER) | Positive and Negative Syndrome Scale (PANSS) Scores at Baseline | 108.25 scores on a scale | Standard Deviation 23.897 |
Secondary
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
Population: Per Protocol (PP) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Extended-release (ER) | Positive and Negative Syndrome Scale (PANSS) Scores at Day 90 | 48.74 scores on a scale | Standard Deviation 18.371 |
Secondary
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
Population: Per Protocol (PP) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Extended-release (ER) | Quality of Sleep at Baseline | 33.99 scores on a scale | Standard Deviation 30.091 |
Secondary
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
Population: Per Protocol (PP) population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Extended-release (ER) | Quality of Sleep at Day 90 | 86.56 scores on a scale | Standard Deviation 18.684 |