Trial Outcomes & Findings for A Trial Comparing Risperidone Long-Acting Injection With Oral Antipsychotic in the Treatment of Early Psychosis (NCT NCT00246259)
NCT ID: NCT00246259
Last Updated: 2013-12-11
Results Overview
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.
COMPLETED
PHASE4
77 participants
Baseline, Week 104 or LRV
2013-12-11
Participant Flow
Participant milestones
| Measure |
Risperidone Long-acting Injection (LAI)
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
41
|
|
Overall Study
Eligible for Intent-to-treat (ITT)
|
42
|
35
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
28
|
26
|
Reasons for withdrawal
| Measure |
Risperidone Long-acting Injection (LAI)
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Overall Study
Other
|
3
|
3
|
|
Overall Study
Not stable by Week 18
|
2
|
1
|
|
Overall Study
Participant non-compliant
|
4
|
9
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
|
Overall Study
Investigator withdrew participant
|
2
|
0
|
|
Overall Study
Adverse Event
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
randomly assigned, not eligible for ITT
|
2
|
6
|
Baseline Characteristics
A Trial Comparing Risperidone Long-Acting Injection With Oral Antipsychotic in the Treatment of Early Psychosis
Baseline characteristics by cohort
| Measure |
Risperidone Long-acting Injection (LAI)
n=42 Participants
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=35 Participants
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
22.5 Years
STANDARD_DEVIATION 3.12 • n=93 Participants
|
23.0 Years
STANDARD_DEVIATION 2.93 • n=4 Participants
|
22.7 Years
STANDARD_DEVIATION 3.03 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 104 or LRVPopulation: 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 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.
Outcome measures
| Measure |
Risperidone Long-acting Injection (LAI)
n=42 Participants
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=35 Participants
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 104 or Last Reported Visit (LRV)
Baseline (n=42, 35)
|
80.6 Units on a scale
Standard Deviation 12.22
|
79.7 Units on a scale
Standard Deviation 12.47
|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 104 or Last Reported Visit (LRV)
Change at Week 104 or LRV (n=42, 34)
|
-18.1 Units on a scale
Standard Deviation 22.48
|
-17.7 Units on a scale
Standard Deviation 16.45
|
PRIMARY outcome
Timeframe: Week 10 (post-stability) up to Week 104 or LRVPopulation: 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.
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)".
Outcome measures
| Measure |
Risperidone Long-acting Injection (LAI)
n=42 Participants
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=35 Participants
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Time to Relapse
|
80.5 Weeks
Standard Deviation 6.3
|
79.5 Weeks
Standard Deviation 4.1
|
PRIMARY outcome
Timeframe: Baseline, Week 104 or LRVPopulation: 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 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.
Outcome measures
| Measure |
Risperidone Long-acting Injection (LAI)
n=42 Participants
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=35 Participants
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) at Week 104 or LRV
Baseline (n=42, 35)
|
53.4 Units on a scale
Standard Deviation 11.23
|
49.5 Units on a scale
Standard Deviation 12.93
|
|
Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) at Week 104 or LRV
Change at Week 104 or LRV (n=34, 28)
|
4.6 Units on a scale
Standard Deviation 16.82
|
9.5 Units on a scale
Standard Deviation 15.24
|
SECONDARY outcome
Timeframe: Baseline, Week 104 or LRVPopulation: 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.
Outcome measures
| Measure |
Risperidone Long-acting Injection (LAI)
n=42 Participants
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=35 Participants
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Change From Baseline in Calgary Depression Symptom Scale (CDSS) Score at Week 104 or LRV
Baseline (n=42, 35)
|
3.7 Units on a scale
Standard Deviation 3.44
|
3.5 Units on a scale
Standard Deviation 2.80
|
|
Change From Baseline in Calgary Depression Symptom Scale (CDSS) Score at Week 104 or LRV
Change at Week 104 or LRV (n=34, 28)
|
0.1 Units on a scale
Standard Deviation 5.38
|
-1.0 Units on a scale
Standard Deviation 3.12
|
SECONDARY outcome
Timeframe: Baseline, Week 104 or LRVPopulation: 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 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).
Outcome measures
| Measure |
Risperidone Long-acting Injection (LAI)
n=42 Participants
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=35 Participants
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Change From Baseline in Young Mania Rating Scale (YMRS) at Week 104 or LRV
Baseline (n=42,35)
|
4.0 Units on a scale
Standard Deviation 4.02
|
4.3 Units on a scale
Standard Deviation 4.03
|
|
Change From Baseline in Young Mania Rating Scale (YMRS) at Week 104 or LRV
Change at Week 104 or LRV (n=34,28)
|
-1.1 Units on a scale
Standard Deviation 4.35
|
-1.5 Units on a scale
Standard Deviation 3.33
|
SECONDARY outcome
Timeframe: Baseline, Week 104 or LRVPopulation: 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 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.
Outcome measures
| Measure |
Risperidone Long-acting Injection (LAI)
n=42 Participants
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=35 Participants
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score at Week 104 or LRV
Baseline (n=42, 35)
|
7.2 Units on a scale
Standard Deviation 5.94
|
7.3 Units on a scale
Standard Deviation 4.66
|
|
Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score at Week 104 or LRV
Change at Week 104 or LRV (n=34, 28)
|
-0.8 Units on a scale
Standard Deviation 6.23
|
-2.9 Units on a scale
Standard Deviation 4.98
|
SECONDARY outcome
Timeframe: Week 10 (post-stability) up to Week 104 or LRVPopulation: 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.
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)".
Outcome measures
| Measure |
Risperidone Long-acting Injection (LAI)
n=32 Participants
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=31 Participants
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Percentage of Participants With Relapse
|
34.4 Percentage of participants
|
16.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Week -2, 104 or LRVPopulation: 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.
Outcome measures
| Measure |
Risperidone Long-acting Injection (LAI)
n=42 Participants
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=35 Participants
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Number of Participants With Cognitive Assessment Using Trail A
Week -2 (0-26 seconds)
|
13 Participants
|
14 Participants
|
|
Number of Participants With Cognitive Assessment Using Trail A
Week -2 (27-39 seconds)
|
16 Participants
|
9 Participants
|
|
Number of Participants With Cognitive Assessment Using Trail A
Week -2 (40-51 seconds)
|
6 Participants
|
4 Participants
|
|
Number of Participants With Cognitive Assessment Using Trail A
Week -2 (52+ seconds)
|
6 Participants
|
6 Participants
|
|
Number of Participants With Cognitive Assessment Using Trail A
Week -2 (Not reported)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Cognitive Assessment Using Trail A
Week 104 (0-26 seconds)
|
15 Participants
|
16 Participants
|
|
Number of Participants With Cognitive Assessment Using Trail A
Week 104 (27-39 seconds)
|
9 Participants
|
7 Participants
|
|
Number of Participants With Cognitive Assessment Using Trail A
Week 104 (40-51 seconds)
|
4 Participants
|
3 Participants
|
|
Number of Participants With Cognitive Assessment Using Trail A
Week 104 (52+ seconds)
|
2 Participants
|
2 Participants
|
|
Number of Participants With Cognitive Assessment Using Trail A
Week 104 (Not reported)
|
12 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Week -2, 104 or LRVPopulation: 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 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.
Outcome measures
| Measure |
Risperidone Long-acting Injection (LAI)
n=42 Participants
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=35 Participants
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Number of Participants With Cognitive Assessments Using Trail B
Week 104 (121+ seconds)
|
2 Participants
|
3 Participants
|
|
Number of Participants With Cognitive Assessments Using Trail B
Week -2 (0-65 Seconds)
|
17 Participants
|
12 Participants
|
|
Number of Participants With Cognitive Assessments Using Trail B
Week -2 (66-85 seconds)
|
8 Participants
|
5 Participants
|
|
Number of Participants With Cognitive Assessments Using Trail B
Week -2 (86-120 seconds)
|
8 Participants
|
3 Participants
|
|
Number of Participants With Cognitive Assessments Using Trail B
Week -2 (121+ seconds)
|
8 Participants
|
13 Participants
|
|
Number of Participants With Cognitive Assessments Using Trail B
Week -2 (Not reported)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Cognitive Assessments Using Trail B
Week 104 (0-65 seconds)
|
17 Participants
|
16 Participants
|
|
Number of Participants With Cognitive Assessments Using Trail B
Week 104 (66-85 seconds)
|
7 Participants
|
4 Participants
|
|
Number of Participants With Cognitive Assessments Using Trail B
Week 104 (86-120 seconds)
|
4 Participants
|
5 Participants
|
|
Number of Participants With Cognitive Assessments Using Trail B
Week 104 (Not reported)
|
12 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 104 or LRVPopulation: 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.
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.
Outcome measures
| Measure |
Risperidone Long-acting Injection (LAI)
n=40 Participants
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=31 Participants
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Total Words Score Over Time
Baseline (n=40, 31)
|
62.4 Units on a scale
Standard Deviation 19.06
|
59.9 Units on a scale
Standard Deviation 16.49
|
|
Total Words Score Over Time
Week 104 or LRV (n=30, 28)
|
63.1 Units on a scale
Standard Deviation 17.81
|
65.4 Units on a scale
Standard Deviation 18.50
|
SECONDARY outcome
Timeframe: Up to Week 104 or LRVPopulation: 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 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.
Outcome measures
| Measure |
Risperidone Long-acting Injection (LAI)
n=33 Participants
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=27 Participants
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 104 or LRV
|
-0.1 Units on a scale
Standard Deviation 2.08
|
-0.2 Units on a scale
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: Up to Week 104 or LRVPopulation: 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.
Outcome measures
| Measure |
Risperidone Long-acting Injection (LAI)
n=34 Participants
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=29 Participants
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Change From Baseline in Standardized Mental Component Scale Score in Short Form 36 (SF-36) at Week 104 or LRV
|
0.6 Units on a scale
Standard Deviation 14.95
|
4.7 Units on a scale
Standard Deviation 12.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 104 or LRVPopulation: 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.
Outcome measures
| Measure |
Risperidone Long-acting Injection (LAI)
n=42 Participants
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=35 Participants
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment
Baseline: Moderate Akathisia (n=42,35)
|
0 Participants
|
0 Participants
|
|
Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment
Baseline: Absent (n=42,35)
|
29 Participants
|
21 Participants
|
|
Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment
Baseline: Questionable (n=42,35)
|
11 Participants
|
8 Participants
|
|
Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment
Baseline: Mild Akathisia (n=42,35)
|
2 Participants
|
6 Participants
|
|
Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment
Baseline: Marked Akathisia (n=42,35)
|
0 Participants
|
0 Participants
|
|
Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment
Week 104: Absent (n=35,29)
|
21 Participants
|
25 Participants
|
|
Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment
Week 104: Questionable (n=35,29)
|
7 Participants
|
2 Participants
|
|
Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment
Week 104: Mild Akathisia (n=35,29)
|
6 Participants
|
2 Participants
|
|
Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment
Week 104: Moderate Akathisia (n=35,29)
|
1 Participants
|
0 Participants
|
|
Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment
Week 104: Marked Akathisia (n=35,29)
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 104 or LRVPopulation: 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.
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.
Outcome measures
| Measure |
Risperidone Long-acting Injection (LAI)
n=42 Participants
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=34 Participants
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Simpson Angus Scale (SAS)
Week 104 (n=34,29)
|
1.0 Units on a scale
Standard Deviation 1.77
|
1.0 Units on a scale
Standard Deviation 2.10
|
|
Simpson Angus Scale (SAS)
Baseline (n=42,34)
|
1.1 Units on a scale
Standard Deviation 1.90
|
1.2 Units on a scale
Standard Deviation 1.61
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 104 or LRVPopulation: Analysis population included all randomly assigned participants. Here '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.
Outcome measures
| Measure |
Risperidone Long-acting Injection (LAI)
n=42 Participants
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=35 Participants
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Abnormal Involuntary Movement Scale (AIMS)
Week 104 (n=35,29)
|
0.7 Units on a scale
Standard Deviation 1.66
|
0.7 Units on a scale
Standard Deviation 1.37
|
|
Abnormal Involuntary Movement Scale (AIMS)
Baseline (n=42,35)
|
1.1 Units on a scale
Standard Deviation 2.07
|
0.8 Units on a scale
Standard Deviation 1.35
|
Adverse Events
Risperidone Long-acting Injection (LAI)
Oral Antipsychotic
Serious adverse events
| Measure |
Risperidone Long-acting Injection (LAI)
n=44 participants at risk
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=41 participants at risk
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Psychiatric disorders
Alcoholism
|
2.3%
1/44 • Baseline up to Week 104
|
0.00%
0/41 • Baseline up to Week 104
|
|
Psychiatric disorders
Depression
|
2.3%
1/44 • Baseline up to Week 104
|
0.00%
0/41 • Baseline up to Week 104
|
|
Skin and subcutaneous tissue disorders
Skin laceration
|
0.00%
0/44 • Baseline up to Week 104
|
2.4%
1/41 • Baseline up to Week 104
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/44 • Baseline up to Week 104
|
2.4%
1/41 • Baseline up to Week 104
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/44 • Baseline up to Week 104
|
2.4%
1/41 • Baseline up to Week 104
|
|
Psychiatric disorders
Suicidal ideation
|
2.3%
1/44 • Baseline up to Week 104
|
0.00%
0/41 • Baseline up to Week 104
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/44 • Baseline up to Week 104
|
2.4%
1/41 • Baseline up to Week 104
|
Other adverse events
| Measure |
Risperidone Long-acting Injection (LAI)
n=44 participants at risk
Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
|
Oral Antipsychotic
n=41 participants at risk
Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator's discretion.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
4.5%
2/44 • Baseline up to Week 104
|
2.4%
1/41 • Baseline up to Week 104
|
|
Eye disorders
Vision blurred
|
2.3%
1/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
1/44 • Baseline up to Week 104
|
7.3%
3/41 • Baseline up to Week 104
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
2/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
2/44 • Baseline up to Week 104
|
2.4%
1/41 • Baseline up to Week 104
|
|
Gastrointestinal disorders
Nausea
|
13.6%
6/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
Gastrointestinal disorders
Stomach discomfort
|
4.5%
2/44 • Baseline up to Week 104
|
0.00%
0/41 • Baseline up to Week 104
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
3/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
General disorders
Fatigue
|
25.0%
11/44 • Baseline up to Week 104
|
12.2%
5/41 • Baseline up to Week 104
|
|
Infections and infestations
Bronchitis
|
4.5%
2/44 • Baseline up to Week 104
|
7.3%
3/41 • Baseline up to Week 104
|
|
Infections and infestations
Ear infection
|
0.00%
0/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
Infections and infestations
Gastroenteritis viral
|
4.5%
2/44 • Baseline up to Week 104
|
2.4%
1/41 • Baseline up to Week 104
|
|
Infections and infestations
Influenza
|
4.5%
2/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
Infections and infestations
Nasopharyngitis
|
20.5%
9/44 • Baseline up to Week 104
|
17.1%
7/41 • Baseline up to Week 104
|
|
Infections and infestations
Sinusitis
|
4.5%
2/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
Injury, poisoning and procedural complications
Hand fracture
|
2.3%
1/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
Investigations
Blood cholesterol increased
|
2.3%
1/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
Investigations
Blood prolactin increased
|
11.4%
5/44 • Baseline up to Week 104
|
0.00%
0/41 • Baseline up to Week 104
|
|
Investigations
Blood triglycerides increased
|
4.5%
2/44 • Baseline up to Week 104
|
7.3%
3/41 • Baseline up to Week 104
|
|
Investigations
Weight decreased
|
0.00%
0/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
Investigations
Weight increased
|
22.7%
10/44 • Baseline up to Week 104
|
17.1%
7/41 • Baseline up to Week 104
|
|
Metabolism and nutrition disorders
Increased appetite
|
4.5%
2/44 • Baseline up to Week 104
|
2.4%
1/41 • Baseline up to Week 104
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
4/44 • Baseline up to Week 104
|
0.00%
0/41 • Baseline up to Week 104
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.8%
3/44 • Baseline up to Week 104
|
9.8%
4/41 • Baseline up to Week 104
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.4%
5/44 • Baseline up to Week 104
|
0.00%
0/41 • Baseline up to Week 104
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.8%
3/44 • Baseline up to Week 104
|
2.4%
1/41 • Baseline up to Week 104
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.3%
1/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
1/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
Nervous system disorders
Akathisia
|
4.5%
2/44 • Baseline up to Week 104
|
7.3%
3/41 • Baseline up to Week 104
|
|
Nervous system disorders
Dizziness
|
18.2%
8/44 • Baseline up to Week 104
|
12.2%
5/41 • Baseline up to Week 104
|
|
Nervous system disorders
Dyskinesia
|
2.3%
1/44 • Baseline up to Week 104
|
7.3%
3/41 • Baseline up to Week 104
|
|
Nervous system disorders
Headache
|
34.1%
15/44 • Baseline up to Week 104
|
12.2%
5/41 • Baseline up to Week 104
|
|
Nervous system disorders
Lethargy
|
4.5%
2/44 • Baseline up to Week 104
|
0.00%
0/41 • Baseline up to Week 104
|
|
Nervous system disorders
Paraesthesia
|
4.5%
2/44 • Baseline up to Week 104
|
0.00%
0/41 • Baseline up to Week 104
|
|
Nervous system disorders
Somnolence
|
6.8%
3/44 • Baseline up to Week 104
|
7.3%
3/41 • Baseline up to Week 104
|
|
Nervous system disorders
Tremor
|
6.8%
3/44 • Baseline up to Week 104
|
2.4%
1/41 • Baseline up to Week 104
|
|
Psychiatric disorders
Aggression
|
0.00%
0/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
Psychiatric disorders
Agitation
|
6.8%
3/44 • Baseline up to Week 104
|
0.00%
0/41 • Baseline up to Week 104
|
|
Psychiatric disorders
Anxiety
|
13.6%
6/44 • Baseline up to Week 104
|
9.8%
4/41 • Baseline up to Week 104
|
|
Psychiatric disorders
Depression
|
6.8%
3/44 • Baseline up to Week 104
|
7.3%
3/41 • Baseline up to Week 104
|
|
Psychiatric disorders
Depressive symptom
|
4.5%
2/44 • Baseline up to Week 104
|
0.00%
0/41 • Baseline up to Week 104
|
|
Psychiatric disorders
Hallucination
|
4.5%
2/44 • Baseline up to Week 104
|
2.4%
1/41 • Baseline up to Week 104
|
|
Psychiatric disorders
Insomnia
|
29.5%
13/44 • Baseline up to Week 104
|
17.1%
7/41 • Baseline up to Week 104
|
|
Psychiatric disorders
Psyshotic disorder
|
9.1%
4/44 • Baseline up to Week 104
|
9.8%
4/41 • Baseline up to Week 104
|
|
Psychiatric disorders
Restlessness
|
2.3%
1/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
Reproductive system and breast disorders
Amenorrhoea
|
11.4%
5/44 • Baseline up to Week 104
|
0.00%
0/41 • Baseline up to Week 104
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
4.5%
2/44 • Baseline up to Week 104
|
2.4%
1/41 • Baseline up to Week 104
|
|
Reproductive system and breast disorders
Galactorrhoea
|
4.5%
2/44 • Baseline up to Week 104
|
2.4%
1/41 • Baseline up to Week 104
|
|
Reproductive system and breast disorders
Gynaecomastia
|
4.5%
2/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
4.5%
2/44 • Baseline up to Week 104
|
0.00%
0/41 • Baseline up to Week 104
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.8%
3/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.8%
3/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.5%
2/44 • Baseline up to Week 104
|
2.4%
1/41 • Baseline up to Week 104
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
4.5%
2/44 • Baseline up to Week 104
|
0.00%
0/41 • Baseline up to Week 104
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.5%
2/44 • Baseline up to Week 104
|
7.3%
3/41 • Baseline up to Week 104
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.5%
2/44 • Baseline up to Week 104
|
0.00%
0/41 • Baseline up to Week 104
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
1/44 • Baseline up to Week 104
|
4.9%
2/41 • Baseline up to Week 104
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
3/44 • Baseline up to Week 104
|
2.4%
1/41 • Baseline up to Week 104
|
Additional Information
Director Medical Affairs - CNS
Janssen Inc., Toronto, ON, Canada
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60