A Trial Comparing Risperidone Long-Acting Injection With Oral Antipsychotic in the Treatment of Early Psychosis

The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.

Time frame: Baseline, Week 104 or LRV

Population: Intent-to-treat (ITT) analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. One participant was missing as reported in oral antipsychotic arm. 'n' = participants evaluable for this measure at given time points.

The SOFAS focused exclusively on participants' level of social and occupational functioning. The SOFAS is a 100 point single item scale that rates functioning of a participant. The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information.

Time frame: Baseline, Week 104 or LRV

Population: The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.

Time to relapse was calculated from the start of the maintenance phase to date of relapse according to Csernansky: Psychiatric hospitalization; increased level of psychiatric care from start of maintenance period and 25 percent increase in total PANSS score from first maintenance visit, or 10 points increase where PANSS at start of maintenance period was 40 or less; deliberate self-injury, suicidal or homicidal ideation; violent to others; property damage; or substantial clinical deterioration, defined as Clinical Global Impression of Change (CGI-C) score of 6 (much worse).

Time frame: Week 10 (post-stability) up to Week 104 or LRV

Population: The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment.

The HAM-A is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. The answers range from 0 which signifies a complete lack of that symptom to 4, which indicates a very severe show of anxiety with that symptom. Total score ranges from 0 to 56. Lower score indicates less affected.

Time frame: Baseline, Week 104 or LRV

Population: The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.

Co-morbid depressive symptoms are evaluated by change in CDSS Score which was developed to assess symptoms of depression in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). It consists of 9 items, each scored from 0 (absent) to 3 (severe). The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to endpoint.

Time frame: Baseline, Week 104 or LRV

Population: The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.

The DAI, a 10-item scale to assess how the attitude of schizophrenia participants toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranged from -10 to 10, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. Change: score at observation minus score at baseline.

Time frame: Up to Week 104 or LRV

Population: The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

The SF-36 is a survey of participant health. It calculates two standardized scales: the standardized mental component scale and the standardized physical component scale. The standardized scales are calculated as weighted sums of the 8 scores, which are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range; and standardized mental component scale score is calculated as weighted average of individual item scores on a 0-100 range, where 100 signify highest level of functioning. The change from baseline in mental component scale score was reported.

Time frame: Up to Week 104 or LRV

Population: The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Co-morbid symptoms of mania are evaluated by change in YMRS Score which is an 11-item scale to assess symptoms of mania, Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 (the least) to 60 (the worst).

Time frame: Baseline, Week 104 or LRV

Population: The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'n' = participants evaluable for this measure at given time points.

Cognitive assessments were done using Trail test B, which measured variety of functions, including motor speed, visual scanning, attention and visual motor integration. In Trail B, 2 sets of circles contain numbers and letters, and the participant must connect them in alternating order. Trail B is also a measure of executive functions as it requires planning and decision-making.

Time frame: Week -2, 104 or LRV

Population: The ITT population included all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment.

Cognitive assessments were done using Trail test A which measured variety of functions, including motor speed, visual scanning, attention and visual motor integration. Participants must connect numbered circles in a variety of orders.

Time frame: Week -2, 104 or LRV

Population: The ITT population included all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment.

Relapse was defined according to Csernansky: Psychiatric hospitalization; increased level of psychiatric care from start of maintenance period and 25 percent increase in total PANSS score from first maintenance visit, or 10 points increase where PANSS at start of maintenance period was 40 or less; deliberate self-injury, suicidal or homicidal ideation; violent to others; property damage; or substantial clinical deterioration, defined as CGI-C score of 6 (much worse).

Time frame: Week 10 (post-stability) up to Week 104 or LRV

Population: The ITT analysis population included all the participants who received at least 3 doses of risperidone or 6 weeks of their oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' (number of participants analyzed) = participants evaluable for this measure.

Controlled Word Association Test (COWAT) was used to assess verbal fluency. Participants are given 3 different letters of the alphabet and asked to say as many words beginning with each letter within a controlled time. Participants are then asked to identify as many words as possible in 3 different categories (animals, fruits and vegetables) within a specified period of time. The total score is a sum of all three categories scores. The total score ranges from 0-90, the higher the score the higher the verbal fluency.

Time frame: Baseline, Week 104 or LRV

Population: The ITT population:all participants who received at least 3 doses of risperidone or 6 weeks of oral antipsychotic, and had at least 1 post-baseline efficacy assessment. Here 'N' signifies participants evaluable for this measure and 'n' signifies participants evaluable at each time point for each treatment arm, respectively.

The AIMS is a 12-item scale to provide a numeric measure to the observed abnormal movements in different parts of the body. Information is collected after a brief neurological examination and is scored on a 5-point scale (0=none, 4=severe). Ten items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dental status. Total scores range from 0 to 42 with higher values indicating more severity.

Time frame: Baseline, Week 104 or LRV

Population: Analysis population included all randomly assigned participants. Here 'n' signifies participants evaluable at each time point for each treatment arm, respectively.

The BARS evaluates akathisia (feeling of restlessness) associated with the use of antipsychotic medications, including an objective and a subjective component plus a global impression. Components are rated on a scale of 0 (normal or absence of restlessness)-3 (intense restlessness) and 0 (absent)-5 (severe akathisia) for the global clinical assessment. Number of participants in each global clinical assessment scale are reported.

Time frame: Baseline, Week 104 or LRV

Population: Analysis population included all randomly assigned participants. Here 'n' signifies participants evaluable at each time point for each treatment arm, respectively.

The SAS is a 10-item scale used to measure the symptoms of parkinsonism (slow movements) or parkinsonian side-effects related to the use of antipsychotic medications. The 10 items are rated on a 5-point scale (0=complete absence, 4=extreme presence) after a brief neurological examination and observation of the participants' gait (slow, shuffling walk). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.

Time frame: Baseline, Week 104 or LRV

Population: Analysis population included all randomly assigned participants. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable at each time point for each treatment arm, respectively.