Schizophrenia
Conditions
Keywords
Paliperidone, R076477, Schizophrenia
Brief summary
The purpose of this study is to evaluate the efficacy of paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
Detailed description
This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended Release(ER) in participants with schizophrenia. The total study duration will be approximately of 104 weeks per participant. The study consists of following parts: Screening (that is, 14 days before study commences on Day 1); acute Treatment phase (single-oral dose of paliperidone for 12 weeks, dose ranging from 3 to 12 milligram); Extension phase 1 (12 weeks) and Maintenance treatment which will be followed by additional Extension phase 2 and long-term maintenance treatment. Efficacy of the participants will primarily be evaluated by Clinical Global Impression-Improvement (CGI-I) scale score. Participants' safety will be monitored throughout the study.
Interventions
DRUGPaliperidone
Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Sponsors
Janssen Korea, Ltd., Korea
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
* Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening * Childbearing potential women who consent to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) * Participants who are capable of and willing to fill out the questionnaire for themselves * Participants who are compliant with self-medication or can receive consistent help or support * Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
Exclusion criteria
* Participants with the past history of neuroleptic malignant syndrome (NMS) * Participants with Treatment Resistance history who have failed to be properly treated with more than two other kinds of antipsychotic agents (at least 4 weeks of the therapeutic dose administration) * Participants with severe (pathologic or iatrogenic) gastrointestinal stenosis or participants who can not swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile.) * Participants who have been exposed to the study drug within one month before screening * Participants with significant risk including suicide or aggressive behavior
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population | Week 12 | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. |
| Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population | Week 12 | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population | Week 12 | Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until Week 12 are reported here. |
| Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population | Week 12 | Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until week 12 are reported here. |
| Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population | Baseline, Week 4 and 12 | The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). |
| Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population | Baseline, Week 4 and 12 | The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). |
| Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population | Baseline, Week 4 and 12 | The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. |
| Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population | Baseline, Week 2, 4, 8 and 12 | The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening. |
| Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population | Week 12 | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. |
| Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population | Week 12 | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. |
| Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population | Baseline, Week 2, 4, 8 and 12 | The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening. |
| Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population | Baseline, Week 4 and Week 12 | The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paliperidone Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion. | 491 |
| Total | 491 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 42 |
| Overall Study | Lack of Efficacy | 45 |
| Overall Study | Lost to Follow-up | 36 |
| Overall Study | Other | 13 |
| Overall Study | Withdrawal by Subject | 49 |
Baseline characteristics
| Characteristic | Paliperidone |
|---|---|
| Age, Continuous | 36.7 years STANDARD_DEVIATION 10.44 |
| Sex: Female, Male Female | 247 Participants |
| Sex: Female, Male Male | 244 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 243 / 491 |
| serious Total, serious adverse events | 55 / 491 |
Outcome results
Primary
Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time frame: Week 12
Population: Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paliperidone Extended-release (ER) | Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population | 34.78 Percentage of participants |
Primary
Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time frame: Week 12
Population: Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paliperidone Extended-release (ER) | Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population | 41.92 Percentage of participants |
Secondary
Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population
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.
Time frame: Baseline, Week 2, 4, 8 and 12
Population: Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended-release (ER) | Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population | Baseline | 4.62 Units on a scale | Standard Deviation 0.7 |
| Paliperidone Extended-release (ER) | Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population | Week 2 | 4.08 Units on a scale | Standard Deviation 0.81 |
| Paliperidone Extended-release (ER) | Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population | Week 4 | 3.73 Units on a scale | Standard Deviation 0.87 |
| Paliperidone Extended-release (ER) | Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population | Week 8 | 3.50 Units on a scale | Standard Deviation 0.91 |
| Paliperidone Extended-release (ER) | Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population | Week 12 | 3.29 Units on a scale | Standard Deviation 0.98 |
Secondary
Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population
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.
Time frame: Baseline, Week 2, 4, 8 and 12
Population: Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended-release (ER) | Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population | Baseline | 4.60 Units on a scale | Standard Deviation 0.68 |
| Paliperidone Extended-release (ER) | Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population | Week 2 | 4.02 Units on a scale | Standard Deviation 0.81 |
| Paliperidone Extended-release (ER) | Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population | Week 4 | 3.66 Units on a scale | Standard Deviation 0.85 |
| Paliperidone Extended-release (ER) | Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population | Week 8 | 3.40 Units on a scale | Standard Deviation 0.87 |
| Paliperidone Extended-release (ER) | Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population | Week 12 | 3.10 Units on a scale | Standard Deviation 0.91 |
Secondary
Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population
The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
Time frame: Baseline, Week 4 and 12
Population: Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments. N (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended-release (ER) | Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population | Baseline | -2.34 Units on a scale | Standard Deviation 4.78 |
| Paliperidone Extended-release (ER) | Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population | Week 4 | -3.37 Units on a scale | Standard Deviation 4.53 |
| Paliperidone Extended-release (ER) | Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population | Week 12 | -3.57 Units on a scale | Standard Deviation 4.54 |
Secondary
Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population
The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
Time frame: Baseline, Week 4 and 12
Population: Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. N (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended-release (ER) | Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population | Baseline | -2.39 Units on a scale | Standard Deviation 4.81 |
| Paliperidone Extended-release (ER) | Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population | Week 4 | -3.49 Units on a scale | Standard Deviation 4.53 |
| Paliperidone Extended-release (ER) | Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population | Week 12 | -4.02 Units on a scale | Standard Deviation 4.26 |
Secondary
Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time frame: Week 12
Population: Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Extended-release (ER) | Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population | Very much improved | 5 Participants |
| Paliperidone Extended-release (ER) | Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population | Much improved | 115 Participants |
| Paliperidone Extended-release (ER) | Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population | Minimally Improved | 158 Participants |
| Paliperidone Extended-release (ER) | Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population | No change | 46 Participants |
| Paliperidone Extended-release (ER) | Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population | Minimally worse | 15 Participants |
| Paliperidone Extended-release (ER) | Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population | Much worse | 6 Participants |
| Paliperidone Extended-release (ER) | Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population | Very much worse | 0 Participants |
Secondary
Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time frame: Week 12
Population: Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. N (number of participants analyzed) signifies the participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Extended-release (ER) | Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population | Very much improved | 5 Participants |
| Paliperidone Extended-release (ER) | Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population | Much improved | 104 Participants |
| Paliperidone Extended-release (ER) | Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population | Minimally Improved | 118 Participants |
| Paliperidone Extended-release (ER) | Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population | No change | 28 Participants |
| Paliperidone Extended-release (ER) | Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population | Minimally worse | 5 Participants |
| Paliperidone Extended-release (ER) | Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population | Much worse | 0 Participants |
| Paliperidone Extended-release (ER) | Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population | Very much worse | 0 Participants |
Secondary
Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population
Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until Week 12 are reported here.
Time frame: Week 12
Population: Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paliperidone Extended-release (ER) | Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population | 38.84 Percentage of participants |
Secondary
Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population
Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until week 12 are reported here.
Time frame: Week 12
Population: Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paliperidone Extended-release (ER) | Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population | 41.54 Percentage of Participants |
Secondary
Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population
The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.
Time frame: Baseline, Week 4 and 12
Population: Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended-release (ER) | Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population | Baseline | 49.39 Units on a scale | Standard Deviation 14.69 |
| Paliperidone Extended-release (ER) | Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population | Week 4 | 59.44 Units on a scale | Standard Deviation 13.54 |
| Paliperidone Extended-release (ER) | Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population | Week 12 | 62.76 Units on a scale | Standard Deviation 13.93 |
Secondary
Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population
The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.
Time frame: Baseline, Week 4 and Week 12
Population: Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended-release (ER) | Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population | Baseline | 49.70 Units on a scale | Standard Deviation 14.73 |
| Paliperidone Extended-release (ER) | Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population | Week 4 | 60.27 Units on a scale | Standard Deviation 13.34 |
| Paliperidone Extended-release (ER) | Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population | Week 12 | 64.73 Units on a scale | Standard Deviation 13.09 |