Schizophrenia
Conditions
Keywords
Schizophrenia, R092670, Paliperidone Palmitate, Paliperidone palmitate 1 month formulation (PP1M), Paliperidone palmitate 3 month formulation (PP3M)
Brief summary
The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.
Detailed description
This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), multicenter non-inferiority (the effect of the new treatment is not worse than that of the comparison treatment) study. A new formulation of paliperidone palmitate with a 3-month injection interval (PP3M) is being tested for use as maintenance treatment for subjects with schizophrenia who have been first stabilized on paliperidone palmitate with a 1-month injection interval (PP1M). The study consists of 3 phases: a screening/washout/tolerability phase (up to 21 days); a 17-week open-label (all people know the identity of the intervention) stabilization phase (referred to as the Open-label Phase) and a 48-week fixed dose, randomized, double-blind controlled phase (referred to as the Double-blind Phase). After completion of the Screening Phase, all patients will receive PP1M in the Open-label Phase. During this time, flexible dosing will occur at Weeks 5 and 9. At Week 13 patients are to receive the dose of PP1M that was administered at Week 9. Patients who are clinically stable at the end of the Open-label Phase will enter the Double-blind Phase and will be randomly assigned in a 1:1 ratio to receive fixed doses of PP3M or PP1M.
Interventions
DRUGPP3M 175 mg eq.
Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every third month for 48 weeks.
DRUGPP3M 263 mg eq.
Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every third month for 48 weeks.
DRUGPP3M 350 mg eq.
Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every third month for 48 weeks.
DRUGPP3M 525 mg eq.
Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every third month for 48 weeks.
DRUGPlacebo (20% Intralipid)
Form= injection, route= intramuscular use. One injection monthly when not receiving active medication for 48 weeks.
DRUGPP1M 50 mg eq.
Type= exact number, unit= mg eq., number= 50, form= injection, route= intramuscular use. One injection every month for 48 weeks.
DRUGPP1M 75 mg eq.
Type= exact number, unit= mg eq., number= 75, form= injection, route= intramuscular use. One injection every month for 48 weeks.
DRUGPP1M 100 mg eq.
Type= exact number, unit= mg eq., number= 100, form= injection, route= intramuscular use. One injection every month for 48 weeks.
DRUGPP1M 150 mg eq.
Type= exact number, unit= mg eq., number= 150, form= injection, route= intramuscular use. One injection every month for 48 weeks.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with schizophrenia for more than 1 year and whose symptoms are worsening in the opinion of the investigator * A total score in the Positive and Negative Syndrome Scale (PANSS) between 70 and 120 * Signed informed consent * Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control * Men must agree to use a double-barrier method of birth control * Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG)
Exclusion criteria
* A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis * Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc) * A diagnosis of substance dependence within 6 months before screening * History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia * Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness * Clinically significant findings in biochemistry, hematology, ECG or urinalysis results * Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase | Up to 48 weeks | Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (\>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (\<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (\>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was \<=3 at randomization; had a score of \>=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48 | DB Baseline (Week 17) and 48 week or DB Endpoint | The Clinical Global Impression Severity (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 DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48 | DB Baseline (Week 17) and 48 week or DB Endpoint | The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100. Participants with a 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. |
| Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 | DB Baseline (Week 17) and 48 week or DB Endpoint | The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology). |
| Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 | DB Baseline (Week 17) and 48 week or DB Endpoint | The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology). |
| Change From Baseline in Marder Factor Subscale Score at Week 48 | DB Baseline (Week 17) and 48 week or DB Endpoint | 5 PANSS Marder factor scores (positive symptoms \[range:8 to 56\], negative symptoms \[range: 7 to 49\], disorganized thoughts \[range: 7 to 49\], uncontrolled hostility/excitement \[range: 4 to 28\], and anxiety/depression \[range: 4 to 28\]) were examined to gain insight into the symptoms affected by treatment with the study drug. Negative change from baseline in subscales score for positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression indicates improvement in various symptoms of schizophrenia. |
| Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria | Weeks 41 to 65 | Symptomatic remission criterion was defined as having a simultaneous score of mild or less on all selected PANSS items (P1, P2, P3, N1, N4, N6, G5, and G9). Symptomatic remission was defined for the last 6 months of the Double-blind Phase as meeting the remission criterion during the 6 months prior to the End of study visit during the Double-blind Phase, with one excursion allowed. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Greece, Hungary, Japan, Mexico, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, Ukraine, United States
Participant flow
Pre-assignment details
1429 participants received at least 1 dose of the study agent in the Open-label Phase, out of which 1016 participants were randomized into the Double blind Phase (Safety population).
Participants by arm
| Arm | Count |
|---|---|
| Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle. | 504 |
| Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle. | 512 |
| Total | 1,016 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| DOUBLE BLIND | Adverse Event | 0 | 15 | 13 |
| DOUBLE BLIND | Blind broken by investigator | 0 | 1 | 0 |
| DOUBLE BLIND | Death | 0 | 1 | 2 |
| DOUBLE BLIND | Lost to Follow-up | 0 | 7 | 12 |
| DOUBLE BLIND | Other | 0 | 6 | 12 |
| DOUBLE BLIND | Pregnancy | 0 | 2 | 0 |
| DOUBLE BLIND | Withdrawal by Subject | 0 | 50 | 53 |
| Open Label Phase | Adverse Event | 57 | 0 | 0 |
| Open Label Phase | Death | 2 | 0 | 0 |
| Open Label Phase | excluded from DB Phase | 70 | 0 | 0 |
| Open Label Phase | Lack of Efficacy | 117 | 0 | 0 |
| Open Label Phase | Lost to Follow-up | 21 | 0 | 0 |
| Open Label Phase | Other | 28 | 0 | 0 |
| Open Label Phase | Withdrawal by Subject | 118 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation | Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation |
|---|---|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 12.06 | 39.0 years STANDARD_DEVIATION 11.89 | 38.3 years STANDARD_DEVIATION 12.24 |
| Region of Enrollment Argentina | 30 participants | 14 participants | 16 participants |
| Region of Enrollment Australia | 5 participants | 3 participants | 2 participants |
| Region of Enrollment Austria | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Belgium | 11 participants | 7 participants | 4 participants |
| Region of Enrollment Brazil | 25 participants | 13 participants | 12 participants |
| Region of Enrollment Bulgaria | 28 participants | 12 participants | 16 participants |
| Region of Enrollment Canada | 9 participants | 3 participants | 6 participants |
| Region of Enrollment China | 210 participants | 104 participants | 106 participants |
| Region of Enrollment Czech Republic | 60 participants | 31 participants | 29 participants |
| Region of Enrollment France | 3 participants | 1 participants | 2 participants |
| Region of Enrollment Germany | 12 participants | 8 participants | 4 participants |
| Region of Enrollment Greece | 11 participants | 5 participants | 6 participants |
| Region of Enrollment Hungary | 40 participants | 21 participants | 19 participants |
| Region of Enrollment Japan | 108 participants | 52 participants | 56 participants |
| Region of Enrollment Mexico | 16 participants | 7 participants | 9 participants |
| Region of Enrollment Poland | 37 participants | 17 participants | 20 participants |
| Region of Enrollment Portugal | 21 participants | 11 participants | 10 participants |
| Region of Enrollment Romania | 13 participants | 7 participants | 6 participants |
| Region of Enrollment Russian Federation | 150 participants | 75 participants | 75 participants |
| Region of Enrollment Slovakia | 22 participants | 12 participants | 10 participants |
| Region of Enrollment South Korea | 12 participants | 7 participants | 5 participants |
| Region of Enrollment Spain | 25 participants | 11 participants | 14 participants |
| Region of Enrollment Taiwan | 14 participants | 7 participants | 7 participants |
| Region of Enrollment Ukraine | 64 participants | 35 participants | 29 participants |
| Region of Enrollment United States | 89 participants | 41 participants | 48 participants |
| Sex: Female, Male Female | 477 Participants | 246 Participants | 231 Participants |
| Sex: Female, Male Male | 539 Participants | 258 Participants | 281 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 457 / 1,429 | 212 / 504 | 208 / 512 |
| serious Total, serious adverse events | 101 / 1,429 | 26 / 504 | 37 / 512 |
Outcome results
Primary
Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase
Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (\>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (\<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (\>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was \<=3 at randomization; had a score of \>=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization.
Time frame: Up to 48 weeks
Population: Modified intent-to-treat (mITT) analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase | 91.5 Percentage of Participants |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase | 90.0 Percentage of Participants |
Secondary
Change From Baseline in Marder Factor Subscale Score at Week 48
5 PANSS Marder factor scores (positive symptoms \[range:8 to 56\], negative symptoms \[range: 7 to 49\], disorganized thoughts \[range: 7 to 49\], uncontrolled hostility/excitement \[range: 4 to 28\], and anxiety/depression \[range: 4 to 28\]) were examined to gain insight into the symptoms affected by treatment with the study drug. Negative change from baseline in subscales score for positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression indicates improvement in various symptoms of schizophrenia.
Time frame: DB Baseline (Week 17) and 48 week or DB Endpoint
Population: mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Positive symptoms factor: Baseline | 15.7 Units on a scale | Standard Deviation 3.66 |
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Positive symptoms factor:Change at Endpoint | -1.1 Units on a scale | Standard Deviation 4.61 |
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Negative symptoms factor: Baseline | 16.2 Units on a scale | Standard Deviation 4.03 |
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Negative symptoms factor : Change at Endpoint | -1.4 Units on a scale | Standard Deviation 3.57 |
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Disorganized thoughts factor :Baseline | 14.2 Units on a scale | Standard Deviation 3.2 |
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Disorganized thoughts factor:Change at Endpoint | -1.2 Units on a scale | Standard Deviation 3.36 |
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Uncontrolled hostility Factor:Baseline | 5.2 Units on a scale | Standard Deviation 1.64 |
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Uncontrolled hostility Factor:Change at Endpoint | 0.2 Units on a scale | Standard Deviation 2.31 |
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Anxiety/depression factor:Baseline | 6.1 Units on a scale | Standard Deviation 2.02 |
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Anxiety/depression factor:Change at Endpoint | -0.0 Units on a scale | Standard Deviation 2.69 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Uncontrolled hostility Factor:Change at Endpoint | -0.2 Units on a scale | Standard Deviation 2.21 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Positive symptoms factor: Baseline | 15.8 Units on a scale | Standard Deviation 3.88 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Disorganized thoughts factor:Change at Endpoint | -1.2 Units on a scale | Standard Deviation 3.24 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Positive symptoms factor:Change at Endpoint | -1.4 Units on a scale | Standard Deviation 4.16 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Anxiety/depression factor:Change at Endpoint | -0.2 Units on a scale | Standard Deviation 2.43 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Negative symptoms factor: Baseline | 16.3 Units on a scale | Standard Deviation 3.9 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Uncontrolled hostility Factor:Baseline | 5.4 Units on a scale | Standard Deviation 1.77 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Negative symptoms factor : Change at Endpoint | -1.3 Units on a scale | Standard Deviation 3.8 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Anxiety/depression factor:Baseline | 6.3 Units on a scale | Standard Deviation 2.12 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Baseline in Marder Factor Subscale Score at Week 48 | Disorganized thoughts factor :Baseline | 14.3 Units on a scale | Standard Deviation 3.17 |
Secondary
Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48
The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).
Time frame: DB Baseline (Week 17) and 48 week or DB Endpoint
Population: mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 | Positive subscale: Baseline | 11.9 Units on a scale | Standard Deviation 3.12 |
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 | Positive subscale:Change at Endpoint | -0.6 Units on a scale | Standard Deviation 4.31 |
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 | Negative subscale: Baseline | 17.3 Units on a scale | Standard Deviation 4.27 |
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 | Negative subscale:Change at Endpoint | -1.4 Units on a scale | Standard Deviation 3.63 |
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 | General psychopathology : Baseline | 28.2 Units on a scale | Standard Deviation 4.55 |
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 | General psychopathology : Change at Endpoint | -1.4 Units on a scale | Standard Deviation 6.77 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 | General psychopathology : Baseline | 28.8 Units on a scale | Standard Deviation 4.79 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 | Positive subscale: Baseline | 12.0 Units on a scale | Standard Deviation 3.19 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 | Negative subscale:Change at Endpoint | -1.4 Units on a scale | Standard Deviation 3.67 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 | Positive subscale:Change at Endpoint | -0.9 Units on a scale | Standard Deviation 3.7 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 | General psychopathology : Change at Endpoint | -2.0 Units on a scale | Standard Deviation 6.57 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 | Negative subscale: Baseline | 17.3 Units on a scale | Standard Deviation 4.11 |
Secondary
Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48
The Clinical Global Impression Severity (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: DB Baseline (Week 17) and 48 week or DB Endpoint
Population: mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48 | Baseline | 2.9 Units on a scale | Standard Deviation 0.57 |
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48 | Change from Baseline at DB End point | -0.1 Units on a scale | Standard Deviation 0.84 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48 | Baseline | 2.9 Units on a scale | Standard Deviation 0.66 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48 | Change from Baseline at DB End point | -0.1 Units on a scale | Standard Deviation 0.75 |
Secondary
Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48
The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100. Participants with a 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: DB Baseline (Week 17) and 48 week or DB Endpoint
Population: mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48 | Baseline | 65.5 Units on a scale | Standard Deviation 10.4 |
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48 | Change from Baseline at DB End point | 1.3 Units on a scale | Standard Deviation 10.22 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48 | Baseline | 65.0 Units on a scale | Standard Deviation 11.06 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48 | Change from Baseline at DB End point | 1.9 Units on a scale | Standard Deviation 9.21 |
Secondary
Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48
The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).
Time frame: DB Baseline (Week 17) and 48 week or DB Endpoint
Population: mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 | Baseline | 57.4 Units on a scale | Standard Deviation 8.56 |
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 | Change from Baseline at DB End point | -3.5 Units on a scale | Standard Deviation 12.5 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 | Baseline | 58.1 Units on a scale | Standard Deviation 8.88 |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 | Change from Baseline at DB End point | -4.3 Units on a scale | Standard Deviation 11.78 |
Secondary
Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria
Symptomatic remission criterion was defined as having a simultaneous score of mild or less on all selected PANSS items (P1, P2, P3, N1, N4, N6, G5, and G9). Symptomatic remission was defined for the last 6 months of the Double-blind Phase as meeting the remission criterion during the 6 months prior to the End of study visit during the Double-blind Phase, with one excursion allowed.
Time frame: Weeks 41 to 65
Population: mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double Blind: Paliperidone Palmitate 3 Month Formulation | Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria | 58.4 Percentage of Participants |
| Double Blind: Paliperidone Palmitate 1 Month Formulation | Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria | 59.2 Percentage of Participants |