Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Mean Change in Clinical Global Impression Severity of Schizophrenia (CGI-SS) Score from Visit 2 (Week 1) to Visit 14 (Week 66 [End of Study {EOS}]) |
The CGI-SS will be used to provide a clinical measure of the severity of schizophrenia. It is a single-item Likert scale with a 7-point range (1 indicates none to 7 indicates extreme symptoms). |
Visit 2 (Week 1) to Visit 14 (Week 66 [EOS]) |
|
| Secondary |
Mean Change in CGI-SS Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS]) |
The CGI-SS will be used to provide a clinical measure of the severity of schizophrenia. It is a single-item Likert scale with a 7-point range (1 indicates none to 7 indicates extreme symptoms). |
Visit 6 (Week 25) to Visit 14 (Week 66 [EOS]) |
|
| Secondary |
Mean Change in CGI-SS Score from Visit 2 (Week 1) to Visit 6 (Week 25) |
The CGI-SS will be used to provide a clinical measure of the severity of schizophrenia. It is a single-item Likert scale with a 7-point range (1 indicates none to 7 indicates extreme symptoms). |
Visit 2 (Week 1) to Visit 6 (Week 25) |
|
| Secondary |
Change in Personal and Social Performance (PSP) Scale Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS]) |
The PSP scale assesses the degree of difficulty a participant exhibits over a 7-day period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The impairment of each domain is rated on a 6-point basis, including absent (0), mild (1), moderate (2), marked (3), severe (4), and very severe (5). The higher domain score, therefore, indicates, worse functioning in that area. |
Visit 2 (Week 1) to Visit 14 (Week 66 [EOS]) |
|
| Secondary |
Change in PSP Scale Scores from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS]) |
The PSP scale assesses the degree of difficulty a participant exhibits over a 7-day period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The impairment of each domain is rated on a 6-point basis, including absent (0), mild (1), moderate (2), marked (3), severe (4), and very severe (5). The higher domain score, therefore, indicates, worse functioning in that area. |
Visit 6 (Week 25) to Visit 14 (Week 66 [EOS]) |
|
| Secondary |
Change in PSP Scale Score from Visit 2 (Week 1) to Visit 6 (Week 25) |
The PSP scale assesses the degree of difficulty a participant exhibits over a 7-day period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The impairment of each domain is rated on a 6-point basis, including absent (0), mild (1), moderate (2), marked (3), severe (4), and very severe (5). The higher domain score, therefore, indicates, worse functioning in that area. |
Visit 2 (Week 1) to Visit 6 (Week 25) |
|
| Secondary |
Change in Patient Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS]) |
The patient satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction. |
Visit 2 (Week 1) to Visit 14 (Week 66 [EOS]) |
|
| Secondary |
Change in Patient Satisfaction Rating Scale Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS]) |
The patient satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction. |
Visit 6 (Week 25) to Visit 14 (Week 66 [EOS]) |
|
| Secondary |
Change in Patient Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 6 (Week 25) |
The patient satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction. |
Visit 2 (Week 1) to Visit 6 (Week 25) |
|
| Secondary |
Change in Clinician Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS]) |
The clinician satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction. |
Visit 2 (Week 1) to Visit 14 (Week 66 [EOS]) |
|
| Secondary |
Change in Clinician Satisfaction Rating Scale Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS]) |
The clinician satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction. |
Visit 6 (Week 25) to Visit 14 (Week 66 [EOS]) |
|
| Secondary |
Change in Clinician Satisfaction Rating Scale Score from Visit 2 (Week 1) to Visit 6 (Week 25) |
The clinician satisfaction rating is a 4-item scale. Two items use a Likert scale with a 6-point range (0 [very dissatisfied] to 5 [very satisfied]) and 2 items are multiple-choice (example, "select all that apply"). Higher score indicates greater satisfaction. |
Visit 2 (Week 1) to Visit 6 (Week 25) |
|
| Secondary |
Change in Schizophrenia Quality of Life Scale (SQLS) Score from Visit 2 (Week 1) to Visit 14 (Week 66 [EOS]) |
The SQLS has 33 items covering topics such as psychosocial feelings and vitality. Response options are never, rarely, sometimes, often, or always. Scoring algorithms yield a 0 to 100 scale, with higher scores indicating lower quality of life. |
Visit 2 (Week 1) to Visit 14 (Week 66 [EOS]) |
|
| Secondary |
Change in SQLS Score from Visit 6 (Week 25) to Visit 14 (Week 66 [EOS]) |
The SQLS has 33 items covering topics such as psychosocial feelings and vitality. Response options are never, rarely, sometimes, often, or always. Scoring algorithms yield a 0 to 100 scale, with higher scores indicating lower quality of life. |
Visit 6 (Week 25) to Visit 14 (Week 66 [EOS]) |
|
| Secondary |
Change in SQLS Score from Visit 2 (Week 1) to Visit 6 (Week 25) |
The SQLS has 33 items covering topics such as psychosocial feelings and vitality. Response options are never, rarely, sometimes, often, or always. Scoring algorithms yield a 0 to 100 scale, with higher scores indicating lower quality of life. |
Visit 2 (Week 1) to Visit 6 (Week 25) |
|
| Secondary |
Number of Participants with Treatment-emergent Adverse Events |
An adverse event is any untoward medical occurrence in a clinical study participants administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Treatment-emergent adverse events are adverse events with onset after the initiation of treatment in observation phase and separately for initiation of paliperidone palmitate (PP) in Lead-in phase or that are a consequence of a pre-existing condition that has worsened after each treatment phase starts. |
Up to Week 66 |
|
| Secondary |
Number of Participants with Abnormalities in Clinical Laboratory Measures |
Number of participants with abnormalities in clinical laboratory measures (including serum chemistry, hematology and urinalysis) will be reported. |
Up to Week 66 |
|
| Secondary |
Number of Participants with Abnormalities in Vital Signs |
Number of participants with abnormalities in vital signs (temperature [oral], pulse/heart rate, and blood pressure) will be reported. |
Up to Week 66 |
|
| Secondary |
Number of Participants with Abnormalities in Electrocardiogram (ECG) |
Number of participants with abnormalities in ECG will be reported. |
Up to Week 66 |
|
| Secondary |
Number of Participants with Abnormalities in Physical Examination |
Number of participants with abnormalities in physical examination (including body weight, waist circumference, and height) will be reported. |
Up to Week 66 |
|
| Secondary |
Number of Participants With Pregnancy Outcome as a Safety Measure |
Number of participants with pregnancy outcome will be reported. |
Up to Week 66 |
|
| Secondary |
Number of Participants With Suicidal Ideation and Behavior as Assessed by Columbia Suicide Severity Rating Scale (C-SSRS) Score |
C-SSRS is an approved and standardized scale for the assessment of the severity of suicidality, through clinical interview. The maximum score assigned for each participant will be summarized into one of three categories: no suicidal ideation or behavior (0), suicidal ideation (1-5), suicidal behavior (6-10). Total score ranges from 1 to 10. Higher scores indicate greater severity. Number of participants with suicidal ideation and behavior will be reported. |
Visit 12 (Week 46) to Visit 14 (Week 66 [EOS]) |
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