Trial Outcomes & Findings for Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia (NCT NCT01726335)
NCT ID: NCT01726335
Last Updated: 2014-04-29
Results Overview
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.
COMPLETED
PHASE4
53 participants
Week 2
2014-04-29
Participant Flow
Participant milestones
| Measure |
Risperidone Prolonged Release
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
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|---|---|
|
Overall Study
STARTED
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53
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
| Measure |
Risperidone Prolonged Release
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
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|---|---|
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Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
15
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Exacerbation of psychotic symptoms
|
1
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Baseline Characteristics
Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia
Baseline characteristics by cohort
| Measure |
Risperidone Prolonged Release
n=53 Participants
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
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|---|---|
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Age, Continuous
|
33.6 Years
STANDARD_DEVIATION 9.1 • n=39 Participants
|
|
Sex: Female, Male
Female
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14 Participants
n=39 Participants
|
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Sex: Female, Male
Male
|
39 Participants
n=39 Participants
|
|
Positive and Negative Syndromes Scale (PANSS) Total Score
|
58.80 Units on a scale
STANDARD_DEVIATION 1.82 • n=39 Participants
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PRIMARY outcome
Timeframe: Week 2Population: Intent-to-treat-efficacy evaluation (ITTe) population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.
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.
Outcome measures
| Measure |
Risperidone Prolonged Release
n=51 Participants
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
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|---|---|
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Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2
|
55.53 Units on a scale
Standard Error 1.82
|
PRIMARY outcome
Timeframe: Week 4Population: The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.
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.
Outcome measures
| Measure |
Risperidone Prolonged Release
n=51 Participants
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
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|---|---|
|
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4
|
53.82 Units on a scale
Standard Error 1.83
|
PRIMARY outcome
Timeframe: Week 8Population: The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.
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.
Outcome measures
| Measure |
Risperidone Prolonged Release
n=51 Participants
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
|
|---|---|
|
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8
|
51.28 Units on a scale
Standard Error 1.86
|
PRIMARY outcome
Timeframe: Week 16Population: The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.
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.
Outcome measures
| Measure |
Risperidone Prolonged Release
n=51 Participants
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
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|---|---|
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Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16
|
50.55 Units on a scale
Standard Error 1.98
|
PRIMARY outcome
Timeframe: Week 24Population: The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.
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.
Outcome measures
| Measure |
Risperidone Prolonged Release
n=51 Participants
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
|
|---|---|
|
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24
|
48.95 Units on a scale
Standard Error 2.13
|
PRIMARY outcome
Timeframe: Week 38Population: The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.
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.
Outcome measures
| Measure |
Risperidone Prolonged Release
n=51 Participants
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
|
|---|---|
|
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38
|
47.40 Units on a scale
Standard Error 2.26
|
PRIMARY outcome
Timeframe: Week 50Population: The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.
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.
Outcome measures
| Measure |
Risperidone Prolonged Release
n=51 Participants
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
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|---|---|
|
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50
|
49.72 Units on a scale
Standard Error 2.32
|
SECONDARY outcome
Timeframe: Baseline and Week 2, 4, 8, 16, 24, 38 and 50Population: The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.
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 indicates to "normal, not at all ill" and a rating of 7 indicates "among the most extremely ill participants". Higher scores indicate worsening.
Outcome measures
| Measure |
Risperidone Prolonged Release
n=51 Participants
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
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|---|---|
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Clinical Global Impressions (CGI) - Disease Severity Score
Baseline
|
3.55 Units on a scale
Standard Error 0.13
|
|
Clinical Global Impressions (CGI) - Disease Severity Score
Week 2
|
3.37 Units on a scale
Standard Error 0.13
|
|
Clinical Global Impressions (CGI) - Disease Severity Score
Week 4
|
3.30 Units on a scale
Standard Error 0.13
|
|
Clinical Global Impressions (CGI) - Disease Severity Score
Week 8
|
3.21 Units on a scale
Standard Error 0.13
|
|
Clinical Global Impressions (CGI) - Disease Severity Score
Week 16
|
3.10 Units on a scale
Standard Error 0.14
|
|
Clinical Global Impressions (CGI) - Disease Severity Score
Week 24
|
2.92 Units on a scale
Standard Error 0.15
|
|
Clinical Global Impressions (CGI) - Disease Severity Score
Week 38
|
2.94 Units on a scale
Standard Error 0.15
|
|
Clinical Global Impressions (CGI) - Disease Severity Score
Week 50
|
3.19 Units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline and Week 2, 4, 8, 16, 24 and 50Population: Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
The ESRS is used to assess four types of drug-induced movement disorders administered as a questionnaire. Score range from 0 to 6 (0 is absent and 6 is extremely severe).
Outcome measures
| Measure |
Risperidone Prolonged Release
n=50 Participants
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
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|---|---|
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Extrapyramidal Symptoms Rating Scale (ESRS) Total Score
Baseline
|
0.460 Units on a scale
Standard Error 0.073
|
|
Extrapyramidal Symptoms Rating Scale (ESRS) Total Score
Week 2
|
0.416 Units on a scale
Standard Error 0.072
|
|
Extrapyramidal Symptoms Rating Scale (ESRS) Total Score
Week 4
|
0.272 Units on a scale
Standard Error 0.073
|
|
Extrapyramidal Symptoms Rating Scale (ESRS) Total Score
Week 8
|
0.289 Units on a scale
Standard Error 0.074
|
|
Extrapyramidal Symptoms Rating Scale (ESRS) Total Score
Week 16
|
0.271 Units on a scale
Standard Error 0.079
|
|
Extrapyramidal Symptoms Rating Scale (ESRS) Total Score
Week 24
|
0.221 Units on a scale
Standard Error 0.082
|
|
Extrapyramidal Symptoms Rating Scale (ESRS) Total Score
Week 50
|
0.089 Units on a scale
Standard Error 0.086
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SECONDARY outcome
Timeframe: Screening, and Week 8, 24 and 50Population: ITTs population included all the Participants who received at least one dose of study medication and were reassessed after the start of use. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.
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. 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). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
Outcome measures
| Measure |
Risperidone Prolonged Release
n=51 Participants
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
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|---|---|
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Drug Attitude Inventory (DAI-10)
Screening
|
2.78 Units on a scale
Standard Error 0.62
|
|
Drug Attitude Inventory (DAI-10)
Week 8
|
4.45 Units on a scale
Standard Error 0.64
|
|
Drug Attitude Inventory (DAI-10)
Week 24
|
4.59 Units on a scale
Standard Error 0.69
|
|
Drug Attitude Inventory (DAI-10)
Week 50
|
5.07 Units on a scale
Standard Error 0.77
|
SECONDARY outcome
Timeframe: Baseline and Week 50Population: The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.
The SF-36 is a survey of participant health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections 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 so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.
Outcome measures
| Measure |
Risperidone Prolonged Release
n=51 Participants
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
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|---|---|
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Short Form-36 (SF-36) - Quality of Life
Functional capacity : Baseline
|
79.2 Units on a scale
Standard Deviation 21.4
|
|
Short Form-36 (SF-36) - Quality of Life
Physical aspect : Baseline
|
48.2 Units on a scale
Standard Deviation 40.2
|
|
Short Form-36 (SF-36) - Quality of Life
Pain : Baseline
|
73.7 Units on a scale
Standard Deviation 27.2
|
|
Short Form-36 (SF-36) - Quality of Life
Health General State : Baseline
|
60.7 Units on a scale
Standard Deviation 18.4
|
|
Short Form-36 (SF-36) - Quality of Life
Vitality : Baseline
|
53.8 Units on a scale
Standard Deviation 21.2
|
|
Short Form-36 (SF-36) - Quality of Life
Social Aspect : Baseline
|
56.1 Units on a scale
Standard Deviation 28.0
|
|
Short Form-36 (SF-36) - Quality of Life
Emotional Aspect : Baseline
|
34.9 Units on a scale
Standard Deviation 38.4
|
|
Short Form-36 (SF-36) - Quality of Life
Mental Health : Baseline
|
58.9 Units on a scale
Standard Deviation 21.9
|
|
Short Form-36 (SF-36) - Quality of Life
Functional capacity : Week 50
|
67.9 Units on a scale
Standard Deviation 31.6
|
|
Short Form-36 (SF-36) - Quality of Life
Physical aspect : Week 50
|
52.9 Units on a scale
Standard Deviation 41.3
|
|
Short Form-36 (SF-36) - Quality of Life
Pain : Week 50
|
75.4 Units on a scale
Standard Deviation 29.5
|
|
Short Form-36 (SF-36) - Quality of Life
Health General State : Week 50
|
62.7 Units on a scale
Standard Deviation 19.5
|
|
Short Form-36 (SF-36) - Quality of Life
Vitality : Week 50
|
53.1 Units on a scale
Standard Deviation 18.3
|
|
Short Form-36 (SF-36) - Quality of Life
Social Aspect : Week 50
|
59.9 Units on a scale
Standard Deviation 26.2
|
|
Short Form-36 (SF-36) - Quality of Life
Emotional Aspect : Week 50
|
55.0 Units on a scale
Standard Deviation 41.7
|
|
Short Form-36 (SF-36) - Quality of Life
Mental Health : Week 50
|
56.6 Units on a scale
Standard Deviation 20.6
|
SECONDARY outcome
Timeframe: Screening, and Week 8, 16, 24, 38 and 50Population: The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.
The PSP scale assesses the degree of a participant's dysfunction (ranging from i \[absent\] to vi \[very severe) within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behavior. The overall score ranges from 1 to 100. Based on the 4-domains there was one total score. Participants with a score of 71 to 100 had a mild degree of difficulty; from 31 to 70, varying degrees of disability; participants with scores of 30 or less function so poorly as to require intensive supervision.
Outcome measures
| Measure |
Risperidone Prolonged Release
n=34 Participants
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
|
|---|---|
|
Personal and Social Performance (PSP) Scale Score
Screening
|
60.0 Units on a scale
Standard Error 2.9
|
|
Personal and Social Performance (PSP) Scale Score
Week 8
|
66.4 Units on a scale
Standard Error 2.4
|
|
Personal and Social Performance (PSP) Scale Score
Week 16
|
72.6 Units on a scale
Standard Error 2.3
|
|
Personal and Social Performance (PSP) Scale Score
Week 24
|
71.7 Units on a scale
Standard Error 2.1
|
|
Personal and Social Performance (PSP) Scale Score
Week 38
|
71.8 Units on a scale
Standard Error 2.1
|
|
Personal and Social Performance (PSP) Scale Score
Week 50
|
69.1 Units on a scale
Standard Error 2.2
|
SECONDARY outcome
Timeframe: Screening, and Week 8, 16, 24, 38 and 50Population: The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.
The GAF scale is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) 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.
Outcome measures
| Measure |
Risperidone Prolonged Release
n=34 Participants
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
|
|---|---|
|
Global Assessment of Functioning (GAF) Scale Score
Screening
|
62.6 Units on a scale
Standard Error 3.1
|
|
Global Assessment of Functioning (GAF) Scale Score
Week 8
|
67.5 Units on a scale
Standard Error 2.6
|
|
Global Assessment of Functioning (GAF) Scale Score
Week 16
|
72.5 Units on a scale
Standard Error 2.5
|
|
Global Assessment of Functioning (GAF) Scale Score
Week 24
|
71.4 Units on a scale
Standard Error 2.3
|
|
Global Assessment of Functioning (GAF) Scale Score
Week 38
|
73.9 Units on a scale
Standard Error 2.3
|
|
Global Assessment of Functioning (GAF) Scale Score
Week 50
|
68.6 Units on a scale
Standard Error 2.3
|
Adverse Events
Risperidone Prolonged Release
Serious adverse events
| Measure |
Risperidone Prolonged Release
n=53 participants at risk
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
|
|---|---|
|
Nervous system disorders
Psychomotor hyperactivity
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Psychiatric disorders
Psychotic disorder
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Psychiatric disorders
Schizophrenia
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
Other adverse events
| Measure |
Risperidone Prolonged Release
n=53 participants at risk
Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
|
|---|---|
|
Endocrine disorders
Hyperprolactinaemia
|
5.7%
3/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.7%
3/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
General disorders
Application site pain
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
General disorders
Asthenia
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
General disorders
Feeling jittery
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
General disorders
Irritability
|
3.8%
2/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
General disorders
Oedema
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Immune system disorders
Hypersensitivity
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Infections and infestations
Influenza
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
2/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Investigations
Alanine aminotransferase increased
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Investigations
Blood glucose increased
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Investigations
Blood prolactin increased
|
11.3%
6/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Investigations
Weight decreased
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Investigations
Weight increased
|
13.2%
7/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.7%
3/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.8%
2/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Metabolism and nutrition disorders
Increased appetite
|
3.8%
2/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.7%
3/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Nervous system disorders
Akathisia
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Nervous system disorders
Dizziness
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Nervous system disorders
Dystonia
|
3.8%
2/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Nervous system disorders
Extrapyramidal disorder
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Nervous system disorders
Headache
|
3.8%
2/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Nervous system disorders
Sedation
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Nervous system disorders
Somnolence
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Nervous system disorders
Tremor
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Psychiatric disorders
Abnormal behaviour
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Psychiatric disorders
Anxiety
|
7.5%
4/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Psychiatric disorders
Apathy
|
3.8%
2/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Psychiatric disorders
Delirium
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Psychiatric disorders
Depression
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Psychiatric disorders
Fear
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Psychiatric disorders
Hostility
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Psychiatric disorders
Insomnia
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Psychiatric disorders
Libido decreased
|
22.6%
12/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Psychiatric disorders
Orgasm abnormal
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Psychiatric disorders
Psychotic disorder
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Psychiatric disorders
Schizophrenia
|
5.7%
3/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Psychiatric disorders
Schizophrenia, disorganised type
|
7.5%
4/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Reproductive system and breast disorders
Breast pain
|
3.8%
2/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Reproductive system and breast disorders
Galactorrhoea
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
|
Vascular disorders
Hypertension
|
1.9%
1/53 • Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
|
Additional Information
Medical Group Manager
Janssen-Cilag Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the Principal Investigator is that the Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the Sponsor for review. The Sponsor can require changes to the communication and can extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER