An Efficacy and Safety Study of Long Acting Injectable Risperidone and Oral Risperidone in Participants With Schizophrenia or Schizoaffective Disorder

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.