Schizophrenia
Conditions
Keywords
Schizophrenia, Risperidone, Risperdal
Brief summary
The purpose of this study is to evaluate the efficacy and safety of long acting injectable (LAI) risperidone and oral risperidone treatment on participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) or schizoaffective disorder (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder).
Detailed description
This is a randomized (treatment group assigned by chance), open-label (all involved people know the identity of the study drug), active-controlled study to evaluate the improvement in social functioning among participants with schizophrenia taking LAI risperidone and oral risperidone tablet. The study drug will be administered for 52 weeks in flexible dose (range as per Investigator's discretion) and a total of 11 assessment visits will be conducted per participant, including Screening. The participant may be withdrawn from the trial for any medical reason at the sole discretion of the investigator. Before starting the study treatment, participants undergo the period of switching from the previous medication to risperidone for 4 weeks, and then they will be evaluated for tolerability for 2 weeks (run-in period for stabilizing to risperidone). In this 2-week period, participants will take oral risperidone. The efficacy will be primarily evaluated through Personal and Social Performance Scale. Safety will be evaluated through Abnormal Involuntary Movement Scale, Barnes Akathisia Rating Scale, and Simpson-Angus Rating Scale. Participants' safety will be monitored throughout the study.
Interventions
DRUGRisperidone long acting injectables
Risperidone long acting injectables will be administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. A supplementary oral antipsychotic will also be administered for 3-4 weeks after the initial dose of injection.
Risperidone tablets will be administered orally as 0.5-10 mg daily up to Week 52.
Sponsors
Janssen Korea, Ltd., Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
- Participants who will understand the objectives and necessary procedures of the study and have signed the informed consent form which specified that they were willing to participate in the study - Participants with schizophrenia or schizoaffective disorder requiring long-term antipsychotic drug therapy - Participants with pre-morbid global assessment of functioning score of 71 or higher at Screening - Participants who do not present clinically significant abnormality in biochemistry and electrocardiography - Participants who will be compliant with the study requirements (that is, filling in the questionnaire by themselves) and who are capable of actually performing and willing to implementing them
Exclusion criteria
- Participants who had taken clozapine for the past three months - Participants with mental retardation (Intelligence Quotient less than 70 at the screening) - Participants with history of or currently with a serious disease (cardiovascular, respiratory, neurological \[including seizures or significant cerebrovascular\], renal, hepatic, hematologic, endocrine, immunologic or other systemic disease) including clinically relevant abnormal level - Participants who have an allergic or hypersensitive reaction to risperidone or who are unresponsive to risperidone - Pregnant or lactating female participants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 52 | Baseline and Week 52 | The PSP assesses degree of participant's dysfunction within 4 domains of behavior, socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1=absent to 6=very severe) in each of 4 domains. Based on the 4 domains there will be one total score. Participants with a score of 71 to 100 have a 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 52 | Baseline and Week 52 | The CGI 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 Social Functioning Scale (SFS) Score at Week 52 | Baseline and Week 52 | Social Functioning Scale (SFS) scores from 0 to 223 wherein, following categories were involved: Social Engagement (Score Range 0-15); Interpersonal Communication (Score Range 0-9); Recreational Activities (Score Range 0-45); Social Activities (Score Range 0-66; Independence Competence (Score Range 0-39); Independence Performance (Score Range 0-39); Occupational Activity (Score Range 0-10). Total score is sum of all sub scores and higher score indicates better level of social functioning. |
| Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | Baseline and Week 52 | For emotional and SFS, mean scores of neuroticism-extroversion-openness (NEO) personality test, relationship style questionnaire (RSQ), state-trait anger expression inventory (STAXI), positive affect and negative affect schedule (PANAS), emotional intelligence (EI), beck depression inventory (BDI), and beck anxiety inventory (BAI) scales were calculated. Score ranges for each category as:60-300 for NEO, 30-150 for RSQ, 20-80 for STAXI, 20-100 for PANAS, 8-172 for EI, 0-63 for BDI and BAI. Higher score indicates improvement. |
| Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52 | Baseline and Week 52 | The NCFT is neuropsychological test which measures psychological functions. The VWM was measured by Korean-Wechsler Adults Intelligence Scale (K-WAIS), which consists of two subscales, the Verbal scale (6 subtests) and the Performance scale (5 subtests). The verbal tests were: information, comprehension, arithmetic, digit span, similarities, and vocabulary. Arithmetic and Digit Span test of Verbal WAIS scales was conducted. Arithmetic test (arithmetic questions were asked orally) involved calculations that measured concentration while manipulating mental mathematical problems. Digit span test (children were asked to repeat the orally given sequences of numbers either as heard or in reverse order) measured attention, concentration, and mental control. Here, mean number of correct responses in limited time period are reported for arithmetic (calculation) and Digit span. Increase in number of correct response indicates improvement. |
| Change From Baseline in Trail Making Test Based on Neurocognitive Function Test (NCFT) at Week 52 | Baseline and Week 52 | The NCFT is neuropsychological test which measures psychological functions. The Trail Making Test is composed of two Parts, A and B. Part A consists of 25 circles printed on a sheet of paper. Each circle contains a number from 1 to 25. The participant's task is to connect the circles with a pencil line as quickly as possible, beginning with the number 1 and proceeding in numerical sequence. Part B consists of 25 circles numbered from 1 to 13 and lettered from A to L. The task in Part B is to connect the circles, in sequence, alternating between numbers and letters. Here, mean number of seconds are represented required to complete each Part. |
| Change From Baseline in Working Memory Based on Neurocognitive Function Test (NCFT) at Week 52 | Baseline and Week 52 | The NCFT is neuropsychological test which measures psychological functions. Working memory was assessed using Controlled Oral Word Association Test (COWAT) which measured verbal fluency and is a sub-test of the multilingual aphasia examination. The COWAT uses the three letter set of C, F, and L to assess phonemic fluency. Individuals are given 1 minute to name as many words as possible beginning with one of the letters. The procedure is then repeated for the remaining two letters. More words indicate improvement. |
| Change From Baseline in Continuous Performance Task (CPT) Based on Neurocognitive Function Test (NCFT) at Week 52 | Baseline and Week 52 | The NCFT is neuropsychological test which measures psychological functions. The CPT assessed CPT (Omissions) and CPT (Commissions). Omission errors indicate the number of times the target was presented, but the participant did not respond/click the mouse. High omission rates indicate that the participant is either not paying attention (distractibility) to stimuli or has a sluggish response. Commission errors indicate the number of times the participant responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity. A slow reaction time with high commission and omission errors indicates inattention in general. |
| Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | Baseline and Week 52 | The TOM scale is used to assess the ability of participant to infer other's mental states. It includes recognition that other individuals experience thoughts, feelings, intentions, and desires. It is measured by cartoon task, score ranging from 0-30 and stork task which includes stork task set A (false belief), stork task set B (double bluff, white lie, persuasion, misunderstanding), and physical story, score ranging from 0-12, 0-26 and 0-24 respectively. Higher score indicates improvement. |
| Change From Baseline in Psychosocial Well-being Index (PWI) Score at Week 52 | Baseline and Week 52 | Psychosocial Well-being Index (PWI) is a questionnaire about how the participant feels and how the things had been going with them. Total score ranges from 0 to 135, where lower score indicates worsening. |
| Change From Baseline in Global Assessment of Functioning (GAF) Test Score at Week 52 | Baseline and Week 52 | The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91 to 100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1 to 10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52 | Baseline and Week 52 | 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 Drug Attitude Inventory-10 (DAI-10) Score at Week 52 | Baseline and Week 52 | The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. Score ranges from (-) 10 to 10. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). |
| Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | Baseline and Week 52 | Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 4 questions are related to number of members for outpatients, number of members visiting inpatients, number of affected members and number of visiting inpatients. Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline. |
| Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52 | Baseline and Week 52 | Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 3 questions are related to days of hospitalization, number of days affected by participants and family per participant within reporting interval score. Mean-calculations were done for all questions. Change from Baseline is the value at Week 52 minus value at Baseline. |
| Change From Baseline in Total Outpatients and Inpatients Hours at Week 52 | Baseline and Week 52 | Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 2 questions are related to total outpatients and inpatients hours. Total outpatients hours and total inpatient hours indicate the total hours spent by outpatients and inpatients respectively at Investigator site.Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline. |
| Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52 | Baseline and Week 52 | Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 3 questions are related to travelling fee for outpatients, hospitalization travelling fee and salary paid a participant before being ill. Mean-calculations were done for all questions. Travelling fee, hospitalization travelling fee and salary paid were assessed for every past three months. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline. |
| Change From Baseline in Number of Outpatient Clinic Visits at Week 52 | Baseline and Week 52 | Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 1 question is related to number of outpatient clinic visits. Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline. |
| Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Week 52 | Baseline and Week 52 | The AIMS rates the severity of involuntary movements from 0 (none) to 4 (severe), including facial and oral movements, extremity movements, trunk movements, global and judgments, and 2 additional items concerning dental status (yes/no). A total score (ranging from 0 to 28) will be calculated as the sum of items 1 to 7. |
| Change From Baseline in Simpson and Angus Rating Scale (SAS) Score at Week 52 | Baseline and Week 52 | The SAS rates 10 items from 0 (normal) to 4 (extreme), including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head rotation, Glabellar tap, tremor and salivation. The SAS global score is the average score (total sum of items score divided by the number of items) and ranges between 0 and 4, where the higher score denotes more severe condition of extra pyramidal symptoms. |
| Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 52 | Baseline and Week 52 | The BARS includes an objective rating, 2 subjective ratings of symptoms of akathisia (awareness of restlessness and reported distress related to restlessness: ranging from 0 to 3), and a global clinical rating of akathisia (GCRA), ranging from 0 (absent) to 5 (severe). The global rating score, that is scored separately, is the most relevant measure of severity of akathisia. Higher scores denote worsening akathisia. |
| Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Score at Week 52 | Baseline and Week 52 | The SUMD scale is a semi-structured scale that assesses participant's awareness of and insight into their illness, that is, the present level of insight. SUMD total score ranges from 0-27, with higher scores indicating poorer insight. The scale consists of nine items score ranging from 1 to 3, with higher scores indicating poorer insight. Score for each item is summed to produce the total score. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Risperidone Injection Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. | 17 |
| Risperidone Tablets Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52. | 24 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 |
| Overall Study | Loss of follow-up & Adverse events | 2 | 1 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Other | 2 | 0 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | protocol Violation & Adverse events | 2 | 4 |
| Overall Study | Study medication not administered | 17 | 13 |
Baseline characteristics
| Characteristic | Risperidone Injection | Risperidone Tablets | Total |
|---|---|---|---|
| Age, Continuous | 36.9 years STANDARD_DEVIATION 10.5 | 32.8 years STANDARD_DEVIATION 9.4 | 34.5 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 9 Participants | 16 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 20 | 13 / 25 |
| serious Total, serious adverse events | 0 / 20 | 0 / 25 |
Outcome results
Primary
Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 52
The PSP assesses degree of participant's dysfunction within 4 domains of behavior, socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1=absent to 6=very severe) in each of 4 domains. Based on the 4 domains there will be one total score. Participants with a score of 71 to 100 have a 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 and Week 52
Population: Intent-to-treat (ITT) population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 52 | Baseline | 50.65 units on a scale | Standard Deviation 14.19 |
| Risperidone Long Acting Injectables | Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 52 | Change at Week 52 | 5.35 units on a scale | Standard Deviation 9.95 |
| Risperidone Tablets | Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 52 | Baseline | 58.71 units on a scale | Standard Deviation 9.82 |
| Risperidone Tablets | Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 52 | Change at Week 52 | 5.96 units on a scale | Standard Deviation 11.22 |
Comparison: Change from Baseline in Personal and Social Performance (PSP) Scale Score at Week 52p-value: 0.859595% CI: [-7.5, 6.3]t-test, 2 sided
Secondary
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Week 52
The AIMS rates the severity of involuntary movements from 0 (none) to 4 (severe), including facial and oral movements, extremity movements, trunk movements, global and judgments, and 2 additional items concerning dental status (yes/no). A total score (ranging from 0 to 28) will be calculated as the sum of items 1 to 7.
Time frame: Baseline and Week 52
Population: Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Week 52 | Baseline (n=20,25) | 0 units on a scale | Full Range 4.6 |
| Risperidone Long Acting Injectables | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Week 52 | Change at Week 52 (n=19,20) | 0 units on a scale | Full Range 5.6 |
| Risperidone Tablets | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Week 52 | Baseline (n=20,25) | 0 units on a scale | Full Range 4.1 |
| Risperidone Tablets | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Week 52 | Change at Week 52 (n=19,20) | 0 units on a scale | Full Range 4.8 |
Secondary
Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 52
The BARS includes an objective rating, 2 subjective ratings of symptoms of akathisia (awareness of restlessness and reported distress related to restlessness: ranging from 0 to 3), and a global clinical rating of akathisia (GCRA), ranging from 0 (absent) to 5 (severe). The global rating score, that is scored separately, is the most relevant measure of severity of akathisia. Higher scores denote worsening akathisia.
Time frame: Baseline and Week 52
Population: Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 52 | Restlessness total score: Baseline(n=20,25) | 0.80 Units on a scale | Standard Deviation 1.11 |
| Risperidone Long Acting Injectables | Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 52 | GCRA: Baseline(n=20,25) | 0.40 Units on a scale | Standard Deviation 0.6 |
| Risperidone Long Acting Injectables | Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 52 | Restlessness total score:Change at Week52(n=19,22) | -0.16 Units on a scale | Standard Deviation 1.12 |
| Risperidone Long Acting Injectables | Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 52 | GCRA: Change at Week 52(n=19,22) | 0.05 Units on a scale | Standard Deviation 0.71 |
| Risperidone Tablets | Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 52 | GCRA: Change at Week 52(n=19,22) | -0.09 Units on a scale | Standard Deviation 0.68 |
| Risperidone Tablets | Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 52 | Restlessness total score: Baseline(n=20,25) | 0.40 Units on a scale | Standard Deviation 0.71 |
| Risperidone Tablets | Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 52 | Restlessness total score:Change at Week52(n=19,22) | 0.00 Units on a scale | Standard Deviation 0.87 |
| Risperidone Tablets | Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 52 | GCRA: Baseline(n=20,25) | 0.32 Units on a scale | Standard Deviation 0.48 |
Secondary
Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 52
The CGI 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 and Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 52 | Baseline | 3.4 units on a scale | Standard Deviation 1.3 |
| Risperidone Long Acting Injectables | Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 52 | Change at Week 52 | -0.6 units on a scale | Standard Deviation 0.9 |
| Risperidone Tablets | Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 52 | Baseline | 2.8 units on a scale | Standard Deviation 1.1 |
| Risperidone Tablets | Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 52 | Change at Week 52 | -0.7 units on a scale | Standard Deviation 1.1 |
Secondary
Change From Baseline in Continuous Performance Task (CPT) Based on Neurocognitive Function Test (NCFT) at Week 52
The NCFT is neuropsychological test which measures psychological functions. The CPT assessed CPT (Omissions) and CPT (Commissions). Omission errors indicate the number of times the target was presented, but the participant did not respond/click the mouse. High omission rates indicate that the participant is either not paying attention (distractibility) to stimuli or has a sluggish response. Commission errors indicate the number of times the participant responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity. A slow reaction time with high commission and omission errors indicates inattention in general.
Time frame: Baseline and Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication \& fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Continuous Performance Task (CPT) Based on Neurocognitive Function Test (NCFT) at Week 52 | CPT (Omissions):Baseline (n=11,15) | 11.0 Errors | Standard Deviation 13.5 |
| Risperidone Long Acting Injectables | Change From Baseline in Continuous Performance Task (CPT) Based on Neurocognitive Function Test (NCFT) at Week 52 | CPT (Comissions):Baseline (n=11,15) | 17.4 Errors | Standard Deviation 37.1 |
| Risperidone Long Acting Injectables | Change From Baseline in Continuous Performance Task (CPT) Based on Neurocognitive Function Test (NCFT) at Week 52 | CPT (Omissions):Change at Week 52 (n=7,12) | 1.6 Errors | Standard Deviation 17.5 |
| Risperidone Long Acting Injectables | Change From Baseline in Continuous Performance Task (CPT) Based on Neurocognitive Function Test (NCFT) at Week 52 | CPT (Comissions):Change at Week 52 (n=7,12) | -3.9 Errors | Standard Deviation 4.1 |
| Risperidone Tablets | Change From Baseline in Continuous Performance Task (CPT) Based on Neurocognitive Function Test (NCFT) at Week 52 | CPT (Comissions):Change at Week 52 (n=7,12) | -0.6 Errors | Standard Deviation 2.3 |
| Risperidone Tablets | Change From Baseline in Continuous Performance Task (CPT) Based on Neurocognitive Function Test (NCFT) at Week 52 | CPT (Omissions):Baseline (n=11,15) | 14.2 Errors | Standard Deviation 34.3 |
| Risperidone Tablets | Change From Baseline in Continuous Performance Task (CPT) Based on Neurocognitive Function Test (NCFT) at Week 52 | CPT (Omissions):Change at Week 52 (n=7,12) | -12.2 Errors | Standard Deviation 38.4 |
| Risperidone Tablets | Change From Baseline in Continuous Performance Task (CPT) Based on Neurocognitive Function Test (NCFT) at Week 52 | CPT (Comissions):Baseline (n=11,15) | 29.3 Errors | Standard Deviation 54.5 |
Secondary
Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52
Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 3 questions are related to days of hospitalization, number of days affected by participants and family per participant within reporting interval score. Mean-calculations were done for all questions. Change from Baseline is the value at Week 52 minus value at Baseline.
Time frame: Baseline and Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication \& fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52 | Days affected:Change at Week 52(n=3,10) | -30.0 days | Standard Deviation 52 |
| Risperidone Long Acting Injectables | Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52 | Hospitalization days:Change at Week 52(n=3,12) | -14.0 days | Standard Deviation 24.2 |
| Risperidone Long Acting Injectables | Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52 | Hospitalization days:Baseline(n=11,18) | 19.4 days | Standard Deviation 21.3 |
| Risperidone Long Acting Injectables | Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52 | Family affected days:Baseline(n=9,12) | 2.9 days | Standard Deviation 4.8 |
| Risperidone Long Acting Injectables | Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52 | Family affected days:Change at Week 52(n=4,10) | -0.3 days | Standard Deviation 2.1 |
| Risperidone Long Acting Injectables | Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52 | Days affected:Baseline(n=8,11) | 34.0 days | Standard Deviation 46.4 |
| Risperidone Tablets | Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52 | Family affected days:Change at Week 52(n=4,10) | -1.5 days | Standard Deviation 3.2 |
| Risperidone Tablets | Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52 | Hospitalization days:Baseline(n=11,18) | 9.8 days | Standard Deviation 13.4 |
| Risperidone Tablets | Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52 | Days affected:Baseline(n=8,11) | 24.3 days | Standard Deviation 34.5 |
| Risperidone Tablets | Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52 | Family affected days:Baseline(n=9,12) | 2.0 days | Standard Deviation 3.4 |
| Risperidone Tablets | Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52 | Hospitalization days:Change at Week 52(n=3,12) | -10.0 days | Standard Deviation 15 |
| Risperidone Tablets | Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52 | Days affected:Change at Week 52(n=3,10) | -25.3 days | Standard Deviation 33.1 |
Secondary
Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Score at Week 52
The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. Score ranges from (-) 10 to 10. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant).
Time frame: Baseline and Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication \& fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Score at Week 52 | Baseline (n=15,18) | 4.1 units on a scale | Standard Deviation 4.6 |
| Risperidone Long Acting Injectables | Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Score at Week 52 | Change at Week 52 (n=7,15) | -4.7 units on a scale | Standard Deviation 7.8 |
| Risperidone Tablets | Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Score at Week 52 | Baseline (n=15,18) | 5.0 units on a scale | Standard Deviation 4.1 |
| Risperidone Tablets | Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Score at Week 52 | Change at Week 52 (n=7,15) | -1.1 units on a scale | Standard Deviation 5.9 |
Secondary
Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52
For emotional and SFS, mean scores of neuroticism-extroversion-openness (NEO) personality test, relationship style questionnaire (RSQ), state-trait anger expression inventory (STAXI), positive affect and negative affect schedule (PANAS), emotional intelligence (EI), beck depression inventory (BDI), and beck anxiety inventory (BAI) scales were calculated. Score ranges for each category as:60-300 for NEO, 30-150 for RSQ, 20-80 for STAXI, 20-100 for PANAS, 8-172 for EI, 0-63 for BDI and BAI. Higher score indicates improvement.
Time frame: Baseline and Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication \& fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | STAXI: Baseline (n=16,21) | 37.4 units on a scale | Standard Deviation 11.7 |
| Risperidone Long Acting Injectables | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | NEO personality test:Change at Week 52 (n=9,17) | -1.1 units on a scale | Standard Deviation 23.8 |
| Risperidone Long Acting Injectables | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | RSQ: Change at Week 52 (n=9,17) | -4.1 units on a scale | Standard Deviation 16.7 |
| Risperidone Long Acting Injectables | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | PANAS: Baseline (n=16,21) | 55.1 units on a scale | Standard Deviation 14.4 |
| Risperidone Long Acting Injectables | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | STAXI:Change at Week 52 (n=9,17) | 0.3 units on a scale | Standard Deviation 11.6 |
| Risperidone Long Acting Injectables | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | RSQ: Baseline (n=16,21) | 84.1 units on a scale | Standard Deviation 18.9 |
| Risperidone Long Acting Injectables | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | PANAS: Change at Week 52 (n=9,17) | -2.8 units on a scale | Standard Deviation 14.2 |
| Risperidone Long Acting Injectables | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | BDI: Baseline (n=16,21) | 14.8 units on a scale | Standard Deviation 11.3 |
| Risperidone Long Acting Injectables | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | EI: Change at Week 52 (n=9,17) | 2.2 units on a scale | Standard Deviation 25.5 |
| Risperidone Long Acting Injectables | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | EI: Baseline (n=16,21) | 151.4 units on a scale | Standard Deviation 23.1 |
| Risperidone Long Acting Injectables | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | BDI:Change at Week 52 (n=9,17) | 1.7 units on a scale | Standard Deviation 9.6 |
| Risperidone Long Acting Injectables | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | BAI: Baseline (n=16,21) | 17.9 units on a scale | Standard Deviation 16.9 |
| Risperidone Long Acting Injectables | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | BAI: Change at Week 52 (n=9,17) | 0.9 units on a scale | Standard Deviation 12.2 |
| Risperidone Long Acting Injectables | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | NEO personality test: Baseline (n=16,21) | 178.7 units on a scale | Standard Deviation 21.8 |
| Risperidone Tablets | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | BAI: Change at Week 52 (n=9,17) | -3.9 units on a scale | Standard Deviation 12.1 |
| Risperidone Tablets | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | NEO personality test: Baseline (n=16,21) | 173.7 units on a scale | Standard Deviation 22.9 |
| Risperidone Tablets | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | EI: Baseline (n=16,21) | 152.9 units on a scale | Standard Deviation 26.4 |
| Risperidone Tablets | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | RSQ: Baseline (n=16,21) | 87.1 units on a scale | Standard Deviation 14.8 |
| Risperidone Tablets | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | STAXI: Baseline (n=16,21) | 31.7 units on a scale | Standard Deviation 10.8 |
| Risperidone Tablets | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | PANAS: Baseline (n=16,21) | 51.0 units on a scale | Standard Deviation 10.6 |
| Risperidone Tablets | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | BDI: Baseline (n=16,21) | 16.9 units on a scale | Standard Deviation 15 |
| Risperidone Tablets | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | BAI: Baseline (n=16,21) | 15.3 units on a scale | Standard Deviation 13.9 |
| Risperidone Tablets | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | NEO personality test:Change at Week 52 (n=9,17) | 2.2 units on a scale | Standard Deviation 21 |
| Risperidone Tablets | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | RSQ: Change at Week 52 (n=9,17) | -8.5 units on a scale | Standard Deviation 26.3 |
| Risperidone Tablets | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | STAXI:Change at Week 52 (n=9,17) | -0.2 units on a scale | Standard Deviation 15.6 |
| Risperidone Tablets | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | PANAS: Change at Week 52 (n=9,17) | -2.8 units on a scale | Standard Deviation 17.3 |
| Risperidone Tablets | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | EI: Change at Week 52 (n=9,17) | 2.4 units on a scale | Standard Deviation 19.5 |
| Risperidone Tablets | Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52 | BDI:Change at Week 52 (n=9,17) | -6.3 units on a scale | Standard Deviation 11.1 |
Secondary
Change From Baseline in Global Assessment of Functioning (GAF) Test Score at Week 52
The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91 to 100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1 to 10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.
Time frame: Baseline and Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Global Assessment of Functioning (GAF) Test Score at Week 52 | Baseline (n=17,24) | 58.3 units on a scale | Standard Deviation 16.7 |
| Risperidone Long Acting Injectables | Change From Baseline in Global Assessment of Functioning (GAF) Test Score at Week 52 | Change at Week 52 (n=8,17) | 5.4 units on a scale | Standard Deviation 11.2 |
| Risperidone Tablets | Change From Baseline in Global Assessment of Functioning (GAF) Test Score at Week 52 | Change at Week 52 (n=8,17) | 5.7 units on a scale | Standard Deviation 15.2 |
| Risperidone Tablets | Change From Baseline in Global Assessment of Functioning (GAF) Test Score at Week 52 | Baseline (n=17,24) | 63.4 units on a scale | Standard Deviation 10.5 |
p-value: 0.956995% CI: [-12.8, 12.2]Student's t-test
Secondary
Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52
Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 4 questions are related to number of members for outpatients, number of members visiting inpatients, number of affected members and number of visiting inpatients. Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.
Time frame: Baseline and Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication \& fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | Members visiting inpatients (MVI):Baseline(n=6,9) | 2.2 participants | Standard Deviation 2.1 |
| Risperidone Long Acting Injectables | Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | Members for outpatients:Change at Week 52(n=8,13) | -0.3 participants | Standard Deviation 0.5 |
| Risperidone Long Acting Injectables | Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | MVI:Change at Week52(n=0,3) | 0 participants | Standard Deviation 0 |
| Risperidone Long Acting Injectables | Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | Affected members:Baseline(n=11,14) | 0.6 participants | Standard Deviation 0.7 |
| Risperidone Long Acting Injectables | Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | Affected members:Change at Week52(n=4,10) | -0.3 participants | Standard Deviation 0.5 |
| Risperidone Long Acting Injectables | Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | Members for outpatients:Baseline(n=13,16) | 0.8 participants | Standard Deviation 0.4 |
| Risperidone Long Acting Injectables | Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | Visiting inpatients:Change at Week52(n=0,3) | 0 participants | Standard Deviation 0 |
| Risperidone Long Acting Injectables | Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | Visiting inpatients:Baseline(n=7,8) | 6.0 participants | Standard Deviation 6.6 |
| Risperidone Tablets | Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | Visiting inpatients:Change at Week52(n=0,3) | -5.0 participants | Standard Deviation 5 |
| Risperidone Tablets | Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | Members for outpatients:Change at Week 52(n=8,13) | -0.3 participants | Standard Deviation 0.6 |
| Risperidone Tablets | Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | Members for outpatients:Baseline(n=13,16) | 0.7 participants | Standard Deviation 0.7 |
| Risperidone Tablets | Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | Affected members:Baseline(n=11,14) | 0.7 participants | Standard Deviation 1 |
| Risperidone Tablets | Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | Visiting inpatients:Baseline(n=7,8) | 6.1 participants | Standard Deviation 4.6 |
| Risperidone Tablets | Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | MVI:Change at Week52(n=0,3) | -2.7 participants | Standard Deviation 3.1 |
| Risperidone Tablets | Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | Affected members:Change at Week52(n=4,10) | -0.4 participants | Standard Deviation 0.7 |
| Risperidone Tablets | Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52 | Members visiting inpatients (MVI):Baseline(n=6,9) | 2.9 participants | Standard Deviation 2.6 |
Secondary
Change From Baseline in Number of Outpatient Clinic Visits at Week 52
Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 1 question is related to number of outpatient clinic visits. Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.
Time frame: Baseline and Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication \& fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Number of Outpatient Clinic Visits at Week 52 | Outpatient clinic visits:Baseline(n=13,20) | 4.7 number of visits | Standard Deviation 4.2 |
| Risperidone Long Acting Injectables | Change From Baseline in Number of Outpatient Clinic Visits at Week 52 | Outpatient clinic visits:Change at Week 52(n=7,14) | 2.4 number of visits | Standard Deviation 6.3 |
| Risperidone Tablets | Change From Baseline in Number of Outpatient Clinic Visits at Week 52 | Outpatient clinic visits:Baseline(n=13,20) | 4.4 number of visits | Standard Deviation 2.5 |
| Risperidone Tablets | Change From Baseline in Number of Outpatient Clinic Visits at Week 52 | Outpatient clinic visits:Change at Week 52(n=7,14) | 1.1 number of visits | Standard Deviation 3.1 |
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52
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 Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52 | Baseline | 78.0 units on a scale | Standard Deviation 11.4 |
| Risperidone Long Acting Injectables | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52 | Change at Week 52 | -11.7 units on a scale | Standard Deviation 18.8 |
| Risperidone Tablets | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52 | Baseline | 69.5 units on a scale | Standard Deviation 11.9 |
| Risperidone Tablets | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52 | Change at Week 52 | -13.0 units on a scale | Standard Deviation 15.7 |
Comparison: Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52p-value: 0.811895% CI: [-9.6, 12.2]t-test, 2 sided
Secondary
Change From Baseline in Psychosocial Well-being Index (PWI) Score at Week 52
Psychosocial Well-being Index (PWI) is a questionnaire about how the participant feels and how the things had been going with them. Total score ranges from 0 to 135, where lower score indicates worsening.
Time frame: Baseline and Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication \& fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Psychosocial Well-being Index (PWI) Score at Week 52 | Baseline (n=16,22) | 93.8 units on a scale | Standard Deviation 21.9 |
| Risperidone Long Acting Injectables | Change From Baseline in Psychosocial Well-being Index (PWI) Score at Week 52 | Change at Week 52 (n=9,18) | 10.7 units on a scale | Standard Deviation 22.1 |
| Risperidone Tablets | Change From Baseline in Psychosocial Well-being Index (PWI) Score at Week 52 | Baseline (n=16,22) | 96.0 units on a scale | Standard Deviation 14.2 |
| Risperidone Tablets | Change From Baseline in Psychosocial Well-being Index (PWI) Score at Week 52 | Change at Week 52 (n=9,18) | 0.7 units on a scale | Standard Deviation 15.1 |
Comparison: Change from Baseline in Psychosocial Well-being Index (PWI) Score at Week 52p-value: 0.176895% CI: [-4.8, 24.8]Student's t-test
Secondary
Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Score at Week 52
The SUMD scale is a semi-structured scale that assesses participant's awareness of and insight into their illness, that is, the present level of insight. SUMD total score ranges from 0-27, with higher scores indicating poorer insight. The scale consists of nine items score ranging from 1 to 3, with higher scores indicating poorer insight. Score for each item is summed to produce the total score.
Time frame: Baseline and Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Score at Week 52 | Baseline (n=17,24) | 12.1 units on a scale | Standard Deviation 5.1 |
| Risperidone Long Acting Injectables | Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Score at Week 52 | Change at Week 52 (n=6,17) | -4.8 units on a scale | Standard Deviation 6.2 |
| Risperidone Tablets | Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Score at Week 52 | Baseline (n=17,24) | 10.6 units on a scale | Standard Deviation 5 |
| Risperidone Tablets | Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Score at Week 52 | Change at Week 52 (n=6,17) | -3.5 units on a scale | Standard Deviation 3.5 |
p-value: 0.529495% CI: [-5.5, 2.9]t-test, 2 sided
Secondary
Change From Baseline in Simpson and Angus Rating Scale (SAS) Score at Week 52
The SAS rates 10 items from 0 (normal) to 4 (extreme), including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head rotation, Glabellar tap, tremor and salivation. The SAS global score is the average score (total sum of items score divided by the number of items) and ranges between 0 and 4, where the higher score denotes more severe condition of extra pyramidal symptoms.
Time frame: Baseline and Week 52
Population: Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Simpson and Angus Rating Scale (SAS) Score at Week 52 | Baseline (n=20,25) | 0 units on a scale | Full Range 4.6 |
| Risperidone Long Acting Injectables | Change From Baseline in Simpson and Angus Rating Scale (SAS) Score at Week 52 | Change at Week 52 (n=19,22) | 0 units on a scale | Full Range 5.6 |
| Risperidone Tablets | Change From Baseline in Simpson and Angus Rating Scale (SAS) Score at Week 52 | Baseline (n=20,25) | 0 units on a scale | Full Range 4.1 |
| Risperidone Tablets | Change From Baseline in Simpson and Angus Rating Scale (SAS) Score at Week 52 | Change at Week 52 (n=19,22) | 0 units on a scale | Full Range 4.8 |
Secondary
Change From Baseline in Social Functioning Scale (SFS) Score at Week 52
Social Functioning Scale (SFS) scores from 0 to 223 wherein, following categories were involved: Social Engagement (Score Range 0-15); Interpersonal Communication (Score Range 0-9); Recreational Activities (Score Range 0-45); Social Activities (Score Range 0-66; Independence Competence (Score Range 0-39); Independence Performance (Score Range 0-39); Occupational Activity (Score Range 0-10). Total score is sum of all sub scores and higher score indicates better level of social functioning.
Time frame: Baseline and Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication \& fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Social Functioning Scale (SFS) Score at Week 52 | Baseline (n=16, 23) | 99.6 units on a scale | Standard Deviation 27 |
| Risperidone Long Acting Injectables | Change From Baseline in Social Functioning Scale (SFS) Score at Week 52 | Change at Week 52 (n=4,14) | 2.3 units on a scale | Standard Deviation 5.9 |
| Risperidone Tablets | Change From Baseline in Social Functioning Scale (SFS) Score at Week 52 | Baseline (n=16, 23) | 103.5 units on a scale | Standard Deviation 33.2 |
| Risperidone Tablets | Change From Baseline in Social Functioning Scale (SFS) Score at Week 52 | Change at Week 52 (n=4,14) | 9.6 units on a scale | Standard Deviation 30.2 |
Secondary
Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52
The TOM scale is used to assess the ability of participant to infer other's mental states. It includes recognition that other individuals experience thoughts, feelings, intentions, and desires. It is measured by cartoon task, score ranging from 0-30 and stork task which includes stork task set A (false belief), stork task set B (double bluff, white lie, persuasion, misunderstanding), and physical story, score ranging from 0-12, 0-26 and 0-24 respectively. Higher score indicates improvement.
Time frame: Baseline and Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication \& fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | Stork Task Set A: Baseline (n=9,12) | 6.0 units on a scale | Standard Deviation 2 |
| Risperidone Long Acting Injectables | Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | Stork Task Set A:Change at Week 52(n=7,11) | 1.0 units on a scale | Standard Deviation 3.6 |
| Risperidone Long Acting Injectables | Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | Cartoon task:Baseline (n=11,13) | 13.8 units on a scale | Standard Deviation 8.7 |
| Risperidone Long Acting Injectables | Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | Stork Task Set B: Baseline (n=11,14) | 14.2 units on a scale | Standard Deviation 6.2 |
| Risperidone Long Acting Injectables | Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | Cartoon task:Change at Week 52(n=7,11) | 5.0 units on a scale | Standard Deviation 7.9 |
| Risperidone Long Acting Injectables | Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | Stork Task Set B:Change at Week 52(n=4,8) | 1.0 units on a scale | Standard Deviation 8.3 |
| Risperidone Long Acting Injectables | Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | Physical story: Baseline (n=11,14) | 12.0 units on a scale | Standard Deviation 5 |
| Risperidone Long Acting Injectables | Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | Physical story:Change at Week 52(n=7,11) | 1.4 units on a scale | Standard Deviation 5.2 |
| Risperidone Tablets | Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | Physical story:Change at Week 52(n=7,11) | 2.1 units on a scale | Standard Deviation 3.9 |
| Risperidone Tablets | Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | Cartoon task:Change at Week 52(n=7,11) | 2.7 units on a scale | Standard Deviation 3.9 |
| Risperidone Tablets | Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | Stork Task Set A:Change at Week 52(n=7,11) | 0.8 units on a scale | Standard Deviation 4.8 |
| Risperidone Tablets | Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | Physical story: Baseline (n=11,14) | 13.6 units on a scale | Standard Deviation 4.4 |
| Risperidone Tablets | Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | Cartoon task:Baseline (n=11,13) | 18.5 units on a scale | Standard Deviation 9.3 |
| Risperidone Tablets | Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | Stork Task Set A: Baseline (n=9,12) | 6.6 units on a scale | Standard Deviation 2.8 |
| Risperidone Tablets | Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | Stork Task Set B:Change at Week 52(n=4,8) | 1.5 units on a scale | Standard Deviation 3.6 |
| Risperidone Tablets | Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52 | Stork Task Set B: Baseline (n=11,14) | 15.5 units on a scale | Standard Deviation 6.8 |
Secondary
Change From Baseline in Total Outpatients and Inpatients Hours at Week 52
Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 2 questions are related to total outpatients and inpatients hours. Total outpatients hours and total inpatient hours indicate the total hours spent by outpatients and inpatients respectively at Investigator site.Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.
Time frame: Baseline and Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Total Outpatients and Inpatients Hours at Week 52 | Total outpatients hours:Change at Week 52(n=4,9) | 0.1 hours | Standard Deviation 1 |
| Risperidone Long Acting Injectables | Change From Baseline in Total Outpatients and Inpatients Hours at Week 52 | Total outpatients hours:Baseline(n=9,13) | 1.7 hours | Standard Deviation 1 |
| Risperidone Long Acting Injectables | Change From Baseline in Total Outpatients and Inpatients Hours at Week 52 | Total inpatient hours:Change at Week 52(n=0,3) | 0.0 hours | Standard Deviation 0 |
| Risperidone Long Acting Injectables | Change From Baseline in Total Outpatients and Inpatients Hours at Week 52 | Total inpatient hours:Baseline(n=5,8) | 1.4 hours | Standard Deviation 1.5 |
| Risperidone Tablets | Change From Baseline in Total Outpatients and Inpatients Hours at Week 52 | Total inpatient hours:Change at Week 52(n=0,3) | -1.0 hours | Standard Deviation 1 |
| Risperidone Tablets | Change From Baseline in Total Outpatients and Inpatients Hours at Week 52 | Total outpatients hours:Baseline(n=9,13) | 1.6 hours | Standard Deviation 0.7 |
| Risperidone Tablets | Change From Baseline in Total Outpatients and Inpatients Hours at Week 52 | Total outpatients hours:Change at Week 52(n=4,9) | -0.2 hours | Standard Deviation 0.4 |
| Risperidone Tablets | Change From Baseline in Total Outpatients and Inpatients Hours at Week 52 | Total inpatient hours:Baseline(n=5,8) | 1.4 hours | Standard Deviation 0.9 |
Secondary
Change From Baseline in Trail Making Test Based on Neurocognitive Function Test (NCFT) at Week 52
The NCFT is neuropsychological test which measures psychological functions. The Trail Making Test is composed of two Parts, A and B. Part A consists of 25 circles printed on a sheet of paper. Each circle contains a number from 1 to 25. The participant's task is to connect the circles with a pencil line as quickly as possible, beginning with the number 1 and proceeding in numerical sequence. Part B consists of 25 circles numbered from 1 to 13 and lettered from A to L. The task in Part B is to connect the circles, in sequence, alternating between numbers and letters. Here, mean number of seconds are represented required to complete each Part.
Time frame: Baseline and Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication \& fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Trail Making Test Based on Neurocognitive Function Test (NCFT) at Week 52 | Trail B Making Test:Baseline (n=11,15) | 146.0 Seconds | Standard Deviation 74.2 |
| Risperidone Long Acting Injectables | Change From Baseline in Trail Making Test Based on Neurocognitive Function Test (NCFT) at Week 52 | Trail A Making Test:Change at Week 52 (n=7,12) | 5.9 Seconds | Standard Deviation 14.9 |
| Risperidone Long Acting Injectables | Change From Baseline in Trail Making Test Based on Neurocognitive Function Test (NCFT) at Week 52 | Trail B Making Test:Change at Week 52 (n=7,12) | -32.3 Seconds | Standard Deviation 59.3 |
| Risperidone Long Acting Injectables | Change From Baseline in Trail Making Test Based on Neurocognitive Function Test (NCFT) at Week 52 | Trail A Making Test:Baseline (n=11,15) | 52.6 Seconds | Standard Deviation 26.6 |
| Risperidone Tablets | Change From Baseline in Trail Making Test Based on Neurocognitive Function Test (NCFT) at Week 52 | Trail B Making Test:Change at Week 52 (n=7,12) | -19.5 Seconds | Standard Deviation 37.9 |
| Risperidone Tablets | Change From Baseline in Trail Making Test Based on Neurocognitive Function Test (NCFT) at Week 52 | Trail A Making Test:Change at Week 52 (n=7,12) | -7.8 Seconds | Standard Deviation 10.3 |
| Risperidone Tablets | Change From Baseline in Trail Making Test Based on Neurocognitive Function Test (NCFT) at Week 52 | Trail A Making Test:Baseline (n=11,15) | 50.7 Seconds | Standard Deviation 28.9 |
| Risperidone Tablets | Change From Baseline in Trail Making Test Based on Neurocognitive Function Test (NCFT) at Week 52 | Trail B Making Test:Baseline (n=11,15) | 147.3 Seconds | Standard Deviation 118.2 |
Secondary
Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52
Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 3 questions are related to travelling fee for outpatients, hospitalization travelling fee and salary paid a participant before being ill. Mean-calculations were done for all questions. Travelling fee, hospitalization travelling fee and salary paid were assessed for every past three months. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.
Time frame: Baseline and Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication \& fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52 | Hospitalization fee:Baseline(n=4,6) | 3500.0 Won | Standard Deviation 4725.8 |
| Risperidone Long Acting Injectables | Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52 | TFO:Change at Week 52(n=12,14) | -658.3 Won | Standard Deviation 2168 |
| Risperidone Long Acting Injectables | Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52 | Hospitalization fee:Change at Week 52(n=0,3) | 0 Won | Standard Deviation 0 |
| Risperidone Long Acting Injectables | Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52 | Travel fee for outpatient(TFO):Baseline(n=12,14) | 4645.8 Won | Standard Deviation 4739.6 |
| Risperidone Long Acting Injectables | Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52 | Salary paid:Change at Week 52(n=3,6) | 0 Won | Standard Deviation 0 |
| Risperidone Long Acting Injectables | Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52 | Salary paid:Baseline(n=4,6) | 0.0 Won | Standard Deviation 0 |
| Risperidone Tablets | Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52 | Salary paid:Change at Week 52(n=3,6) | -3000.0 Won | Standard Deviation 7348.5 |
| Risperidone Tablets | Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52 | TFO:Change at Week 52(n=12,14) | 183.3 Won | Standard Deviation 10837.4 |
| Risperidone Tablets | Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52 | Travel fee for outpatient(TFO):Baseline(n=12,14) | 4850.0 Won | Standard Deviation 6401.1 |
| Risperidone Tablets | Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52 | Hospitalization fee:Baseline(n=4,6) | 9500.0 Won | Standard Deviation 8043.6 |
| Risperidone Tablets | Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52 | Salary paid:Baseline(n=4,6) | 3000.0 Won | Standard Deviation 7348.5 |
| Risperidone Tablets | Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52 | Hospitalization fee:Change at Week 52(n=0,3) | -7333.3 Won | Standard Deviation 9451.6 |
Secondary
Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52
The NCFT is neuropsychological test which measures psychological functions. The VWM was measured by Korean-Wechsler Adults Intelligence Scale (K-WAIS), which consists of two subscales, the Verbal scale (6 subtests) and the Performance scale (5 subtests). The verbal tests were: information, comprehension, arithmetic, digit span, similarities, and vocabulary. Arithmetic and Digit Span test of Verbal WAIS scales was conducted. Arithmetic test (arithmetic questions were asked orally) involved calculations that measured concentration while manipulating mental mathematical problems. Digit span test (children were asked to repeat the orally given sequences of numbers either as heard or in reverse order) measured attention, concentration, and mental control. Here, mean number of correct responses in limited time period are reported for arithmetic (calculation) and Digit span. Increase in number of correct response indicates improvement.
Time frame: Baseline and Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication \& fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52 | VWM (Calculation):Baseline (n=11,14) | 7.5 Correct responses | Standard Deviation 2.2 |
| Risperidone Long Acting Injectables | Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52 | VWM (Numbers):Baseline (n=11,14) | 11.6 Correct responses | Standard Deviation 5.1 |
| Risperidone Long Acting Injectables | Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52 | VWM (Calculation):Change at Week 52 (n=7,12) | 2.0 Correct responses | Standard Deviation 2.8 |
| Risperidone Long Acting Injectables | Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52 | VWM (Numbers):Change at Week 52 (n=7,12) | 1.3 Correct responses | Standard Deviation 3.6 |
| Risperidone Tablets | Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52 | VWM (Numbers):Change at Week 52 (n=7,12) | 2.3 Correct responses | Standard Deviation 3.1 |
| Risperidone Tablets | Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52 | VWM (Calculation):Baseline (n=11,14) | 9.3 Correct responses | Standard Deviation 4.1 |
| Risperidone Tablets | Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52 | VWM (Calculation):Change at Week 52 (n=7,12) | 1.0 Correct responses | Standard Deviation 4.1 |
| Risperidone Tablets | Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52 | VWM (Numbers):Baseline (n=11,14) | 11.8 Correct responses | Standard Deviation 4.6 |
Secondary
Change From Baseline in Working Memory Based on Neurocognitive Function Test (NCFT) at Week 52
The NCFT is neuropsychological test which measures psychological functions. Working memory was assessed using Controlled Oral Word Association Test (COWAT) which measured verbal fluency and is a sub-test of the multilingual aphasia examination. The COWAT uses the three letter set of C, F, and L to assess phonemic fluency. Individuals are given 1 minute to name as many words as possible beginning with one of the letters. The procedure is then repeated for the remaining two letters. More words indicate improvement.
Time frame: Baseline and Week 52
Population: ITT population included all randomized participants who received at least one dose of study medication \& fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risperidone Long Acting Injectables | Change From Baseline in Working Memory Based on Neurocognitive Function Test (NCFT) at Week 52 | WM (Coris Block): Change at Week 52 (n=5,9) | 4.6 Words | Standard Deviation 9.6 |
| Risperidone Long Acting Injectables | Change From Baseline in Working Memory Based on Neurocognitive Function Test (NCFT) at Week 52 | WM (Digital Span):Baseline (n=10,12) | 11.6 Words | Standard Deviation 4.7 |
| Risperidone Long Acting Injectables | Change From Baseline in Working Memory Based on Neurocognitive Function Test (NCFT) at Week 52 | WM (Coris Block): Baseline (n=8,13) | 10.5 Words | Standard Deviation 5.3 |
| Risperidone Long Acting Injectables | Change From Baseline in Working Memory Based on Neurocognitive Function Test (NCFT) at Week 52 | WM (Digital Span):Change at Week 52 (n=6,10) | 1.0 Words | Standard Deviation 3.4 |
| Risperidone Tablets | Change From Baseline in Working Memory Based on Neurocognitive Function Test (NCFT) at Week 52 | WM (Digital Span):Change at Week 52 (n=6,10) | 0.5 Words | Standard Deviation 3 |
| Risperidone Tablets | Change From Baseline in Working Memory Based on Neurocognitive Function Test (NCFT) at Week 52 | WM (Coris Block): Change at Week 52 (n=5,9) | -0.7 Words | Standard Deviation 4.7 |
| Risperidone Tablets | Change From Baseline in Working Memory Based on Neurocognitive Function Test (NCFT) at Week 52 | WM (Coris Block): Baseline (n=8,13) | 14.9 Words | Standard Deviation 5.2 |
| Risperidone Tablets | Change From Baseline in Working Memory Based on Neurocognitive Function Test (NCFT) at Week 52 | WM (Digital Span):Baseline (n=10,12) | 14.3 Words | Standard Deviation 5.1 |