| Primary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 104 or Last Reported Visit (LRV) | 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 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. | Intent-to-treat (ITT) analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. One participant was missing as reported in oral antipsychotic arm. 'n' = participants evaluable for this measure at given time points. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 104 or LRV | | | | ID | Title | Description |
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| OG000 | Risperidone Long-acting Injection (LAI) | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. | | OG001 | Oral Antipsychotic | Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion. |
| | | Title | Denominators | Categories |
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| Baseline (n=42, 35) | | | Title | Measurements |
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| - OG00080.6± 12.22
- OG00179.7± 12.47
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| | Change at Week 104 or LRV (n=42, 34) | | |
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| Primary | Time to Relapse | Time to relapse was calculated from the start of the maintenance phase to date of relapse according to Csernansky: "Psychiatric hospitalization; increased level of psychiatric care from start of maintenance period and 25 percent increase in total PANSS score from first maintenance visit, or 10 points increase where PANSS at start of maintenance period was 40 or less; deliberate self-injury, suicidal or homicidal ideation; violent to others; property damage; or substantial clinical deterioration, defined as Clinical Global Impression of Change (CGI-C) score of 6 (much worse)". | The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. | Posted | | Mean | Standard Deviation | Weeks | | Week 10 (post-stability) up to Week 104 or LRV | | | | ID | Title | Description |
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| OG000 | Risperidone Long-acting Injection (LAI) | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. | | OG001 | Oral Antipsychotic | Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion. |
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| Primary | Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) at Week 104 or LRV | The SOFAS focused exclusively on participants' level of social and occupational functioning. The SOFAS is a 100 point single item scale that rates functioning of a participant. The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information. | The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 104 or LRV | | | | ID | Title | Description |
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| OG000 | Risperidone Long-acting Injection (LAI) | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. | | OG001 | Oral Antipsychotic | Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion. |
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| Secondary | Change From Baseline in Calgary Depression Symptom Scale (CDSS) Score at Week 104 or LRV | Co-morbid depressive symptoms are evaluated by change in CDSS Score which was developed to assess symptoms of depression in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). It consists of 9 items, each scored from 0 (absent) to 3 (severe). The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to endpoint. | The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 104 or LRV | | | | ID | Title | Description |
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| OG000 | Risperidone Long-acting Injection (LAI) | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. | | OG001 | Oral Antipsychotic | Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion. |
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| Secondary | Change From Baseline in Young Mania Rating Scale (YMRS) at Week 104 or LRV | Co-morbid symptoms of mania are evaluated by change in YMRS Score which is an 11-item scale to assess symptoms of mania, Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 (the least) to 60 (the worst). | The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 104 or LRV | | | | ID | Title | Description |
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| OG000 | Risperidone Long-acting Injection (LAI) | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. | | OG001 | Oral Antipsychotic | Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion. |
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| Secondary | Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score at Week 104 or LRV | The HAM-A is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. The answers range from 0 which signifies a complete lack of that symptom to 4, which indicates a very severe show of anxiety with that symptom. Total score ranges from 0 to 56. Lower score indicates less affected. | The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 104 or LRV | | | | ID | Title | Description |
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| OG000 | Risperidone Long-acting Injection (LAI) | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. | | OG001 | Oral Antipsychotic | Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion. |
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| Secondary | Percentage of Participants With Relapse | Relapse was defined according to Csernansky: "Psychiatric hospitalization; increased level of psychiatric care from start of maintenance period and 25 percent increase in total PANSS score from first maintenance visit, or 10 points increase where PANSS at start of maintenance period was 40 or less; deliberate self-injury, suicidal or homicidal ideation; violent to others; property damage; or substantial clinical deterioration, defined as CGI-C score of 6 (much worse)". | The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) = participants evaluable for this measure. | Posted | | Number | | Percentage of participants | | Week 10 (post-stability) up to Week 104 or LRV | | | | ID | Title | Description |
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| OG000 | Risperidone Long-acting Injection (LAI) | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. | | OG001 | Oral Antipsychotic | Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion. |
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| Secondary | Number of Participants With Cognitive Assessment Using Trail A | Cognitive assessments were done using Trail test A which measured variety of functions, including motor speed, visual scanning, attention and visual motor integration. Participants must connect numbered circles in a variety of orders. | The ITT population included all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment. | Posted | | Number | | Participants | | Week -2, 104 or LRV | | | | ID | Title | Description |
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| OG000 | Risperidone Long-acting Injection (LAI) | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. | | OG001 | Oral Antipsychotic | Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion. |
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| Secondary | Number of Participants With Cognitive Assessments Using Trail B | Cognitive assessments were done using Trail test B, which measured variety of functions, including motor speed, visual scanning, attention and visual motor integration. In Trail B, 2 sets of circles contain numbers and letters, and the participant must connect them in alternating order. Trail B is also a measure of executive functions as it requires planning and decision-making. | The ITT population included all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment. | Posted | | Number | | Participants | | Week -2, 104 or LRV | | | | ID | Title | Description |
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| OG000 | Risperidone Long-acting Injection (LAI) | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. | | OG001 | Oral Antipsychotic | Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion. |
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| Secondary | Total Words Score Over Time | Controlled Word Association Test (COWAT) was used to assess verbal fluency. Participants are given 3 different letters of the alphabet and asked to say as many words beginning with each letter within a controlled time. Participants are then asked to identify as many words as possible in 3 different categories (animals, fruits and vegetables) within a specified period of time. The total score is a sum of all three categories scores. The total score ranges from 0-90, the higher the score the higher the verbal fluency. | The ITT population:all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' signifies participants evaluable for this measure and 'n' signifies participants evaluable at each time point for each treatment arm, respectively. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 104 or LRV | | | | ID | Title | Description |
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| OG000 | Risperidone Long-acting Injection (LAI) | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. | | OG001 | Oral Antipsychotic | Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion. |
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| Secondary | Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 104 or LRV | The DAI, a 10-item scale to assess how the attitude of schizophrenia participants toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranged from -10 to 10, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. Change: score at observation minus score at baseline. | The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | Units on a scale | | Up to Week 104 or LRV | | | | ID | Title | Description |
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| OG000 | Risperidone Long-acting Injection (LAI) | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. | | OG001 | Oral Antipsychotic | Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion. |
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| Secondary | Change From Baseline in Standardized Mental Component Scale Score in Short Form 36 (SF-36) at Week 104 or LRV | The SF-36 is a survey of participant health. It calculates two standardized scales: the standardized mental component scale and the standardized physical component scale. The standardized scales are calculated as weighted sums of the 8 scores, which are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range; and standardized mental component scale score is calculated as weighted average of individual item scores on a 0-100 range, where 100 signify highest level of functioning. The change from baseline in mental component scale score was reported. | The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | Units on a scale | | Up to Week 104 or LRV | | | | ID | Title | Description |
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| OG000 | Risperidone Long-acting Injection (LAI) | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. | | OG001 |
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| Other Pre-specified | Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment | The BARS evaluates akathisia (feeling of restlessness) associated with the use of antipsychotic medications, including an objective and a subjective component plus a global impression. Components are rated on a scale of 0 (normal or absence of restlessness)-3 (intense restlessness) and 0 (absent)-5 (severe akathisia) for the global clinical assessment. Number of participants in each global clinical assessment scale are reported. | Analysis population included all randomly assigned participants. Here 'n' signifies participants evaluable at each time point for each treatment arm, respectively. | Posted | | Number | | Participants | | Baseline, Week 104 or LRV | | | | ID | Title | Description |
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| OG000 | Risperidone Long-acting Injection (LAI) | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. | | OG001 | Oral Antipsychotic | Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion. |
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| Other Pre-specified | Simpson Angus Scale (SAS) | The SAS is a 10-item scale used to measure the symptoms of parkinsonism (slow movements) or parkinsonian side-effects related to the use of antipsychotic medications. The 10 items are rated on a 5-point scale (0=complete absence, 4=extreme presence) after a brief neurological examination and observation of the participants' gait (slow, shuffling walk). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected. | Analysis population included all randomly assigned participants. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point for each treatment arm, respectively. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 104 or LRV | | | | ID | Title | Description |
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| OG000 | Risperidone Long-acting Injection (LAI) | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. | | OG001 | Oral Antipsychotic | Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion. |
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| Other Pre-specified | Abnormal Involuntary Movement Scale (AIMS) | The AIMS is a 12-item scale to provide a numeric measure to the observed abnormal movements in different parts of the body. Information is collected after a brief neurological examination and is scored on a 5-point scale (0=none, 4=severe). Ten items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dental status. Total scores range from 0 to 42 with higher values indicating more severity. | Analysis population included all randomly assigned participants. Here 'n' signifies participants evaluable at each time point for each treatment arm, respectively. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 104 or LRV | | | | ID | Title | Description |
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| OG000 | Risperidone Long-acting Injection (LAI) | Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. | | OG001 | Oral Antipsychotic | Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion. |
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