Schizophrenia
Conditions
Keywords
Schizophrenia, Paliperidone, Aripiprazole
Brief summary
The purpose of this study is to evaluate the efficacy and safety of extended-release (ER) paliperidone compared to aripiprazole (atypical antipsychotic) in symptomatic (having symptoms) adolescent participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations \[imagining things\], and withdrawal into the self) .
Detailed description
This is a multi-center (conducted in more than 1 center), double-blind (neither physician nor participant knows the name of the assigned drug), randomized (study drug is assigned by chance), active-controlled (paliperidone ER is compared to aripiprazole), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different treatments), flexible-dose (the physician has the freedom to give different doses to the participant depending on how they respond to treatment) study designed to determine the efficacy and safety of paliperidone ER in symptomatic adolescents (12 to 17 years of age) with schizophrenia. The total duration of the study will be approximately 29 weeks. The study consists of 3 phases: a Screening phase up to 3 weeks (with a possible overlapping washout period), a Double-blind acute phase of 8 weeks, and a Double-blind maintenance phase of 18 weeks. Participants will be randomly assigned to 1 of the 2 treatment groups (paliperidone ER or aripiprazole flexible oral doses). Dosage will be adjusted at the scheduled visits. Efficacy of the participants will primarily be evaluated through Positive and Negative Syndromes Scale (PANSS). Participants' safety will be monitored throughout the study.
Interventions
Paliperidone ER will be administered as oral capsule at a dose of 6 mg for 1 week and then will be administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
DRUGAripiprazole
Aripiprazole will be administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 mg Days 5, 6 and 7; and then will be administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Participants must currently meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for schizophrenia and have experienced symptoms of the illness for at least 1 year, and they should have had at least treatment with 1 antipsychotic before participation in this study * Participants having a Positive and Negative Syndromes Scale (PANSS) score between 60 and 120 inclusive at Screening * Female participants must be incapable of pregnancy, or if heterosexually active and capable of pregnancy, have been using an acceptable method of contraception for at least 1 month before study entry and agree to continue use contraception methods for the duration of the study, or if sexually abstinent (not having sexual intercourse) and capable of pregnancy, must agree to continue abstinence or to use an acceptable method of birth control * Participants must not be a danger to themselves or others, and must have family support available to be maintained as out-patients * Participants with a weight of equal to or greater than 29 kilogram
Exclusion criteria
* Participants with mild (not serious), moderate (medium level of seriousness), or severe (very serious, life threatening) mental retardation * Participants with a known or suspected history of substance dependence (including alcohol, but excluding nicotine or caffeine) as per the DSM-IV criteria in the 3 months before Screening * Participants with a history of certain neurological (pertaining to the nervous system) disorders or insulin-dependent diabetes mellitus (disorder in which there is decreased insulin in the body or the body's insulin is not effective, resulting in high blood sugar, increased thirst and urine, and many other side effects) * Participants who have received a depot injectable antipsychotic within 2 treatment cycles before the Screening visit * Participants who have received clozapine in 2 months before the Baseline visit (Day 1 of Week 1)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56 | Baseline and Day 56 | The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182 | Baseline, Day 56 and Day 182 | The PANSS negative subscale based on marder factor assesses 7 negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). |
| Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Baseline, Day 56 and 182 | The subscales based on marder factors are: positive symptoms, disorganised thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for Uncontrolled hostility/excitement and anxiety/depression. Higher score indicate worsening. |
| Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Baseline, Day 56 and 182 | The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). |
| Change From Baseline in PANSS Total Score at Day 182 | Baseline and Day 182 | The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening. |
| Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182 | Baseline, Day 56 and 182 | 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. |
| Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182 | Baseline, Day 56 and Day 182 | The PSP scale assesses degree of a participants' dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numerical score to rate degree of difficulty (1=absent to 6=very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score (total score ranges from 1 to 100, divided into 10 equal intervals). Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. |
| Number of Participants With PANSS Response | Day 56 and 182 | The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Participants with PANSS response were defined as those who achieved greater than or equal to 20 percent or higher reduction from Baseline in the PANSS total score at Day 56 and 182. |
| Number of Participants With Clinical Stability | Day 56 and 182 | Clinical stability is defined as a decrease of 20 percent or more from Baseline in PANSS total score and CGI-S score less than or equal to 4 at Days 56 and 182, no hospitalizations due to psychiatric illness and no emergence of clinically significant suicidal or homicidal ideation during the maintenance phase. |
Countries
India, Romania, Russia, Slovakia, Spain, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paliperidone Extended Release (ER) Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. | 112 |
| Aripiprazole Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning. | 114 |
| Total | 226 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 0 |
| Overall Study | Lack of Efficacy | 4 | 11 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Other | 3 | 2 |
| Overall Study | Withdrawal by consent | 16 | 11 |
Baseline characteristics
| Characteristic | Paliperidone Extended Release (ER) | Aripiprazole | Total |
|---|---|---|---|
| Age Continuous | 15.3 Years STANDARD_DEVIATION 1.46 | 15.4 Years STANDARD_DEVIATION 1.45 | 15.3 Years STANDARD_DEVIATION 1.46 |
| Sex: Female, Male Female | 39 Participants | 38 Participants | 77 Participants |
| Sex: Female, Male Male | 73 Participants | 76 Participants | 149 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 63 / 113 | 50 / 114 |
| serious Total, serious adverse events | 7 / 113 | 7 / 114 |
Outcome results
Primary
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56
The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Time frame: Baseline and Day 56
Population: The intent-to-treat (ITT) population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56 | Change at Day 56 | -19.3 Units on a scale | Standard Deviation 13.8 |
| Paliperidone Extended Release (ER) | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56 | Baseline | 89.6 Units on a scale | Standard Deviation 12.22 |
| Aripiprazole | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56 | Change at Day 56 | -19.8 Units on a scale | Standard Deviation 14.56 |
| Aripiprazole | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56 | Baseline | 92.0 Units on a scale | Standard Deviation 12.09 |
p-value: 0.93595% CI: [-3.46, 3.76]ANCOVA
Secondary
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182
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, Day 56 and 182
Population: The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Paliperidone Extended Release (ER) | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182 | Baseline | 4.0 Units on a scale |
| Paliperidone Extended Release (ER) | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182 | Change at Day 56 | -1.0 Units on a scale |
| Paliperidone Extended Release (ER) | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182 | Change at Day 182 | -1.0 Units on a scale |
| Aripiprazole | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182 | Baseline | 4.0 Units on a scale |
| Aripiprazole | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182 | Change at Day 56 | -1 Units on a scale |
| Aripiprazole | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182 | Change at Day 182 | -1.0 Units on a scale |
p-value: 0.843ANCOVA
p-value: 0.914ANCOVA
Secondary
Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182
The PANSS negative subscale based on marder factor assesses 7 negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Time frame: Baseline, Day 56 and Day 182
Population: The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) | Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182 | Baseline | 23.2 Units on a scale | Standard Deviation 4.92 |
| Paliperidone Extended Release (ER) | Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182 | Change at Day 56 | -4.3 Units on a scale | Standard Deviation 4.56 |
| Paliperidone Extended Release (ER) | Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182 | Change at Day 182 | -6.0 Units on a scale | Standard Deviation 5.51 |
| Aripiprazole | Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182 | Baseline | 23.3 Units on a scale | Standard Deviation 4.54 |
| Aripiprazole | Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182 | Change at Day 56 | -4.7 Units on a scale | Standard Deviation 4.61 |
| Aripiprazole | Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182 | Change at Day 182 | -6.2 Units on a scale | Standard Deviation 5.84 |
p-value: 0.34195% CI: [-0.55, 1.59]ANCOVA
p-value: 0.72395% CI: [-1.06, 1.53]ANCOVA
Secondary
Change From Baseline in Other Marder Factors Scores at Day 56 and 182
The subscales based on marder factors are: positive symptoms, disorganised thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for Uncontrolled hostility/excitement and anxiety/depression. Higher score indicate worsening.
Time frame: Baseline, Day 56 and 182
Population: The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Baseline: Negative symptoms | 23.2 Units on a scale | Standard Deviation 4.92 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 56: Disorganized thoughts | -4.0 Units on a scale | Standard Deviation 3.34 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 56: Positive symptoms | -6.1 Units on a scale | Standard Deviation 4.96 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 182: Disorganized thoughts | -5.5 Units on a scale | Standard Deviation 4.18 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 56: Negative symptoms | -4.3 Units on a scale | Standard Deviation 4.56 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Baseline: Uncontrolled hostility | 10.7 Units on a scale | Standard Deviation 3.19 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 56: Uncontrolled hostility | -2.5 Units on a scale | Standard Deviation 2.67 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 182: Positive symptoms | -7.8 Units on a scale | Standard Deviation 5.82 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 182: Negative symptoms | -6.0 Units on a scale | Standard Deviation 5.51 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Baseline: Anxiety/depression | 9.7 Units on a scale | Standard Deviation 3.17 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 182: Uncontrolled hostility | -3.2 Units on a scale | Standard Deviation 3.11 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 56: Anxiety/depression | -2.4 Units on a scale | Standard Deviation 3.08 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Baseline: Disorganized thoughts | 21.4 Units on a scale | Standard Deviation 4.4 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 182: Anxiety/depression | -3.0 Units on a scale | Standard Deviation 3.29 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Baseline: Positive symptoms | 24.6 Units on a scale | Standard Deviation 4.08 |
| Aripiprazole | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 182: Anxiety/depression | -3.2 Units on a scale | Standard Deviation 3.17 |
| Aripiprazole | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 56: Positive symptoms | -5.6 Units on a scale | Standard Deviation 4.83 |
| Aripiprazole | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Baseline: Uncontrolled hostility | 11.7 Units on a scale | Standard Deviation 3.48 |
| Aripiprazole | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Baseline: Positive symptoms | 24.9 Units on a scale | Standard Deviation 4.32 |
| Aripiprazole | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 182: Positive symptoms | -7.8 Units on a scale | Standard Deviation 6.03 |
| Aripiprazole | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Baseline: Negative symptoms | 23.3 Units on a scale | Standard Deviation 4.54 |
| Aripiprazole | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 56: Negative symptoms | -4.7 Units on a scale | Standard Deviation 4.61 |
| Aripiprazole | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 182: Negative symptoms | -6.2 Units on a scale | Standard Deviation 5.84 |
| Aripiprazole | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Baseline: Disorganized thoughts | 22.1 Units on a scale | Standard Deviation 3.86 |
| Aripiprazole | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 56: Disorganized thoughts | -4.1 Units on a scale | Standard Deviation 3.4 |
| Aripiprazole | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 182: Disorganized thoughts | -5.7 Units on a scale | Standard Deviation 4.46 |
| Aripiprazole | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 56: Uncontrolled hostility | -2.9 Units on a scale | Standard Deviation 3.05 |
| Aripiprazole | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 182: Uncontrolled hostility | -3.8 Units on a scale | Standard Deviation 3.97 |
| Aripiprazole | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Baseline: Anxiety/depression | 10.0 Units on a scale | Standard Deviation 3.26 |
| Aripiprazole | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | Change at Day 56: Anxiety/depression | -2.6 Units on a scale | Standard Deviation 2.81 |
p-value: 0.351ANCOVA
p-value: 0.691ANCOVA
p-value: 0.965ANCOVA
p-value: 0.766ANCOVA
p-value: 0.984ANCOVA
p-value: 0.985ANCOVA
p-value: 0.803ANCOVA
p-value: 0.745ANCOVA
Secondary
Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182
The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme).
Time frame: Baseline, Day 56 and 182
Population: The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Baseline: General Psychopathology | 44.3 Units on a scale | Standard Deviation 7.47 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Change at Day 56: Negative Subscale | -4.2 Units on a scale | Standard Deviation 4.25 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Change at Day 182: Positive Subscale | -8.0 Units on a scale | Standard Deviation 5.16 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Change at Day 182: Negative Subscale | -5.7 Units on a scale | Standard Deviation 5.15 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Change at Day 56: Positive Subscale | -6.4 Units on a scale | Standard Deviation 4.54 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Change at Day 56: General Psychopathology | -8.7 Units on a scale | Standard Deviation 7.35 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Baseline: Negative Subscale | 23.8 Units on a scale | Standard Deviation 4.55 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Change at Day 182: General Psychopathology | -11.9 Units on a scale | Standard Deviation 9.02 |
| Paliperidone Extended Release (ER) | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Baseline: Positive Subscale | 21.5 Units on a scale | Standard Deviation 4.14 |
| Aripiprazole | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Change at Day 182: General Psychopathology | -12.4 Units on a scale | Standard Deviation 9.41 |
| Aripiprazole | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Baseline: General Psychopathology | 45.3 Units on a scale | Standard Deviation 7.01 |
| Aripiprazole | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Baseline: Positive Subscale | 22.5 Units on a scale | Standard Deviation 4.26 |
| Aripiprazole | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Change at Day 56: Positive Subscale | -6.2 Units on a scale | Standard Deviation 4.91 |
| Aripiprazole | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Change at Day 182: Positive Subscale | -8.3 Units on a scale | Standard Deviation 6.09 |
| Aripiprazole | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Baseline: Negative Subscale | 24.2 Units on a scale | Standard Deviation 4.32 |
| Aripiprazole | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Change at Day 56: Negative Subscale | 4.5 Units on a scale | Standard Deviation 4.25 |
| Aripiprazole | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Change at Day 182: Negative Subscale | -6.1 Units on a scale | Standard Deviation 5.47 |
| Aripiprazole | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | Change at Day 56: General Psychopathology | -9.1 Units on a scale | Standard Deviation 7.25 |
Secondary
Change From Baseline in PANSS Total Score at Day 182
The PANSS is a 30-item scale 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 and ranges from 30 to 210. Higher scores indicate worsening.
Time frame: Baseline and Day 182
Population: The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) | Change From Baseline in PANSS Total Score at Day 182 | Baseline | 89.6 Units on a scale | Standard Deviation 12.22 |
| Paliperidone Extended Release (ER) | Change From Baseline in PANSS Total Score at Day 182 | Change at Day 182 | -25.6 Units on a scale | Standard Deviation 16.88 |
| Aripiprazole | Change From Baseline in PANSS Total Score at Day 182 | Baseline | 92.0 Units on a scale | Standard Deviation 12.09 |
| Aripiprazole | Change From Baseline in PANSS Total Score at Day 182 | Change at Day 182 | -26.8 Units on a scale | Standard Deviation 18.82 |
p-value: 0.87795% CI: [-4.68, 4]ANCOVA
Secondary
Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182
The PSP scale assesses degree of a participants' dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numerical score to rate degree of difficulty (1=absent to 6=very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score (total score ranges from 1 to 100, divided into 10 equal intervals). Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.
Time frame: Baseline, Day 56 and Day 182
Population: The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) | Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182 | Baseline | 49.8 Units on a Scale | Standard Deviation 10.32 |
| Paliperidone Extended Release (ER) | Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182 | Change at Day 56 | 12.2 Units on a Scale | Standard Deviation 11.72 |
| Paliperidone Extended Release (ER) | Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182 | Change at Day 182 | 17.1 Units on a Scale | Standard Deviation 14.46 |
| Aripiprazole | Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182 | Baseline | 49.2 Units on a Scale | Standard Deviation 10.21 |
| Aripiprazole | Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182 | Change at Day 56 | 12.2 Units on a Scale | Standard Deviation 10.17 |
| Aripiprazole | Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182 | Change at Day 182 | 17.1 Units on a Scale | Standard Deviation 14.03 |
p-value: 0.89595% CI: [-2.34, 2.67]ANCOVA
p-value: 0.70595% CI: [-2.64, 3.89]ANCOVA
Secondary
Number of Participants With Clinical Stability
Clinical stability is defined as a decrease of 20 percent or more from Baseline in PANSS total score and CGI-S score less than or equal to 4 at Days 56 and 182, no hospitalizations due to psychiatric illness and no emergence of clinically significant suicidal or homicidal ideation during the maintenance phase.
Time frame: Day 56 and 182
Population: The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paliperidone Extended Release (ER) | Number of Participants With Clinical Stability | 58 Participants |
| Aripiprazole | Number of Participants With Clinical Stability | 68 Participants |
p-value: 0.296Cochran-Mantel-Haenszel
Secondary
Number of Participants With PANSS Response
The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Participants with PANSS response were defined as those who achieved greater than or equal to 20 percent or higher reduction from Baseline in the PANSS total score at Day 56 and 182.
Time frame: Day 56 and 182
Population: The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Extended Release (ER) | Number of Participants With PANSS Response | Day 56 | 76 Participants |
| Paliperidone Extended Release (ER) | Number of Participants With PANSS Response | Day 182 | 86 Participants |
| Aripiprazole | Number of Participants With PANSS Response | Day 56 | 87 Participants |
| Aripiprazole | Number of Participants With PANSS Response | Day 182 | 93 Participants |
p-value: 0.119Cochran-Mantel-Haenszel
p-value: 0.444Cochran-Mantel-Haenszel