A Study to Evaluate the Effectiveness and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia

The PANSS is scale of 30 items which includes 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is 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).

Marder factor scores of the PANSS, derived by factor-analysis includes 5 factors: negative symptom, positive symptom, disorganized thought, uncontrolled hostility/excitement, and anxiety/depression factor scales. Positive factor score (range: 8 to 56): sum of select scores from positive, negative, and general psychopathology subscales. Negative factor score (range: 7 to 49): sum of select scores from negative and general psychopathology subscales. Disorganized thoughts factor score (range: 7 to 49): sum of select scores from positive, negative, and general psychopathology subscales. Uncontrolled hostility/excitement factor score (range: 4 to 28): sum of select scores from positive and general psychopathology subscales. Anxiety/Depression factor score (range: 4 to 28): sum of select scores from general psychopathology subscale. Higher scores indicate worsening.

The PANSS is scale of 30 items which includes 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). The scale ranges from 1 (absent) to 7 (extreme). Each item is rated on a scale of 1 (absent) to 7 (extreme). The subscale score is the sum of scores of items in the subscale. Positive subscale (range: 7 to 49), negative subscale (range: 7 to 49) and general psychopathology subscale (range: 16 to 112). Higher scores indicate worsening.

The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 to 7 where 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, 7=Among the most extremely ill.

The PSP assesses the overall personal and social functioning on a continuum from grossly impaired functioning to excellent functioning using 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The degree of dysfunction a participant exhibits during the month prior to the assessment is rated on a 6-point scale (1=absent, 2=mild, 3=manifest, 4=marked, 5=severe, 6=very severe). The final total score ranges from 1 - 100 (71 - 100 indicating mild, good or excellent degree of dysfunction, 31 - 70 indicating varying degrees of difficulty, and <=30 indicating such a poor level functioning that intensive supervision is required).

The 6-item RDQ consists of 5 items assessing suicidality/homicidality, control of aggression/impulsivity, activities of daily living, independence in medication-taking, delusions/hallucinations interfering with functioning, on a 4-point scale (1=strongly agree, 2=agree, 3=disagree, 4=strongly disagree), and 1 item assessing CGI-severity <=4 status using a binary (yes/no) response. Using all 6 items as a guide, the clinician provides a final overall "yes/no" answer to the question 'is the participant ready for discharge'.