Time to Relapse After Discontinuation of Risperidone Long-Acting Injection (RLAI) in First-Episode Participants Successfully Treated for 24 Months With RLAI in Previous Study (RIS-PSY-301) (Period 1)
Relapse will be diagnosed if 1 or more of the following occurs: a 25 percent increase in Positive and Negative Syndrome Scale (PANSS) total score ranging from 30 (absent) to 210 (extreme ill); Clinical Global Impression (CGI-C) score of 6 ('much worse'); deliberate self-injury (as per adverse event [AE] reporting); emergence of clinically significant suicidal or homicidal ideation (as per AE reporting); or violent behavior resulting in significant injury to another person or significant property damage (as per AE reporting).
Percentage of Participants who Relapsed After Discontinuation of RLAI (Period 1)
Relapse will be diagnosed if 1 or more of the following occurs: a 25 percent increase in PANSS total score ranging from 30 (absent) to 210 (extreme ill); CGI-C score of 6 ('much worse'); deliberate self-injury (as per AE reporting); emergence of clinically significant suicidal or homicidal ideation (as per AE reporting); or violent behavior resulting in significant injury to another person or significant property damage (as per AE reporting).
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score After Re-Initiation of RLAI, at Month 24 or EW (Period 2)
The PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) and scores for 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.
Time to Treatment Response After Re-Initiation of RLAI (Period 2)
Time to treatment response after re-initiation of RLAI will be the time that elapse between Baseline assessment of PANSS for Period 2 and fulfilment of the response which is defined as greater than or equal to 20 percent improvement in PANSS total score. PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.
Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 36 or EW (Period 1)
The PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) and scores for 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology (GP) subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.
Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 24 or EW (Period 2)
The PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) and scores for 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology (GP) subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.
Change From Baseline in Marder PANSS Subscales Score at Month 36 or EW (Period 1)
The PANSS total score consists of the sum of all 30 PANSS items and score ranges from 30 to 210. Higher scores indicate worsening. The symptoms are rated on a 7-point Marder scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 856; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility (UH) or excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28.
Change From Baseline in Marder PANSS Subscales Score at Month 24 or EW (Period 2)
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point Marder scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, UH or excitement subscale and anxiety or depression subscale, each consists of 4 items with total score range of 4-28. Higher score indicates greater severity.
Number of Participants With Disease Remission Based on PANSS (Period 1)
A participants will be 'in remission' when he/she is symptomatically stable and show progressive improvement in total recovery according to severity (mild or less simultaneously on 8 PANSS items:P1 delusions, P2 conceptual disorganization, P3 hallucinatory behavior, G9 unusual thought content, G5 mannerisms and posturing, N1 blunted affect, N4 social withdrawal, N6 lack of spontaneity or flow of conversation) and time (scores for 8 PANSS items above should not exceed the severity criterion mild at any time point of assessment for at least 6 months to meet the criteria of remission) criteria.
Number of Participants With Disease Remission Based on PANSS (Period 2)
A participants will be 'in remission' when he/she is symptomatically stable and show progressive improvement in total recovery according to severity (mild or less simultaneously on 8 PANSS items:P1 delusions, P2 conceptual disorganization, P3 hallucinatory behavior, G9 unusual thought content, G5 mannerisms and posturing, N1 blunted affect, N4 social withdrawal, N6 lack of spontaneity or flow of conversation) and time (scores for 8 PANSS items above should not exceed the severity criterion mild at any time point of assessment for at least 6 months to meet the criteria of remission) criteria.
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 36 or EW (Period 1)
The CGI-S 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=Normal, not at all ill' and a rating of '7=Among the most extremely ill participants'. Higher scores indicate worsening.
Clinical Global Impression of Change (CGI-C) Score at Month 36 or EW (Period 1)
The CGI-C scale is designed to assess the change in the clinical condition over time. The CGI-C consists of a 7-point rating of change, questioning if the clinical condition of the participant improved, remained unchanged, or worsened.
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 24 or EW (Period 2)
The CGI-S 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=Normal, not at all ill' and a rating of '7=Among the most extremely ill participants'. Higher scores indicate worsening.
Clinical Global Impression of Change (CGI-C) Score in Period 2 at Month 24 or EW (Period 2)
The CGI-C scale is designed to assess the change in the clinical condition over time. The CGI-C consists of a 7-point rating of change, questioning if the clinical condition of the participant improved, remained unchanged, or worsened.
Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 36 or EW (Period 1)
The CDSS assesses the level of depression in participants with schizophrenia. It consists of 9 items: depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression, each scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score is a sum of the scores of each item and may range from 0 to 27. Higher score indicates more severe pathology.
Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 24 or EW (Period 2)
The CDSS assesses the level of depression in participants with schizophrenia. It consists of 9 items: depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression, each scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score is a sum of the scores of each item and may range from 0 to 27. Higher score indicates more severe pathology.
Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 36 or EW (Period 1)
The SOFAS is a 100- point single item scale that assesses level of social and occupational functioning of a participant and is not directly influenced by the overall severity of the individual's psychological symptoms.The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information.
Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 24 or EW (Period 2)
The SOFAS is a 100-point single item scale that assesses level of social and occupational functioning of a participant and is not directly influenced by the overall severity of the individual's psychological symptoms.The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information.
Change From Baseline in Patient Global Impression-Severity (PGI-S) Score at Month 36 or EW (Period 1)
The PGI-S is an 11-point (0=very well to 10=very poor) scale that requires the participants to rate the severity of their illness at the time of assessment, relative to the participant's past experience. The response options are: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse.
Patient Global Impression-Change (PGI-C) Score at Month 36 or EW (Period 1)
The PGI-C is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse .
Change From Baseline in Patient Global Impression-Severity (PGI-S) Score at Month 24 or EW (Period 2)
The PGI-S is an 11-point (0=very well to 10=very poor) scale that requires the participants to rate the severity of their illness at the time of assessment, relative to the participant's past experience. The response options are: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse.
Patient Global Impression-Change (PGI-C) Score at Month 24 or EW (Period 2)
The PGI-C is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse .
Change From Baseline in 12-Item Short-Form (SF-12) Score - Quality of Life Survey at Month 36 or EW (Period 1)
The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in 2 six-item subscales: physical component summary (PCS) and MCS (mental component summary). The SF-12 score ranges from 10=maximum impairment to 70=no impairment.
Change From Baseline in 12-Item Short-Form (SF-12) Score - Quality of Life Survey at Month 24 or EW (Period 2)
The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in 2 six-item subscales: physical component summary (PCS) and MCS (mental component summary). The SF-12 scores range from 10=maximum impairment to 70=no impairment.