Trial Outcomes & Findings for An Efficacy and Safety Study of Long-Term Risperidone Microspheres in Participants With Schizophrenia (NCT NCT00269919)
NCT ID: NCT00269919
Last Updated: 2014-04-16
Results Overview
The PANSS is a 30-item scale consisting of 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items) and it is designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 items are 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 (absent) to 210 (extreme ill). Higher scores indicate worsening.
COMPLETED
PHASE4
40 participants
Baseline and Week 96
2014-04-16
Participant Flow
Participant milestones
| Measure |
Risperidone Long-acting Injection (RLAI)
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly (into a muscle) depending on Investigator's discretion every 2 weeks for 2 years.
|
|---|---|
|
Overall Study
STARTED
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40
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Overall Study
Treated
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39
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Overall Study
COMPLETED
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13
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
Risperidone Long-acting Injection (RLAI)
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly (into a muscle) depending on Investigator's discretion every 2 weeks for 2 years.
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|---|---|
|
Overall Study
Other
|
26
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|
Overall Study
Started but not treated
|
1
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Baseline Characteristics
An Efficacy and Safety Study of Long-Term Risperidone Microspheres in Participants With Schizophrenia
Baseline characteristics by cohort
| Measure |
Risperidone Long-acting Injection (RLAI)
n=39 Participants
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
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|---|---|
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Age, Continuous
|
35.0 Years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
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Sex: Female, Male
Male
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25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 96Population: The intent-to-treat (ITT) analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 efficacy measurement post-baseline. Here, 'N'=the participants who were evaluated for this outcome measure.
The PANSS is a 30-item scale consisting of 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items) and it is designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 items are 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 (absent) to 210 (extreme ill). Higher scores indicate worsening.
Outcome measures
| Measure |
Risperidone Long-Acting Injection (RLAI)
n=37 Participants
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
|
|---|---|
|
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score at Week 96
Baseline
|
73.00 Units on a scale
Standard Deviation 13.98
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Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score at Week 96
Change at Week 96
|
18.24 Units on a scale
Standard Deviation 14.87
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SECONDARY outcome
Timeframe: Baseline and Week 96Population: The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, 'N'=the participants who were evaluated for this outcome measure.
The CGI-S rating scale is used to rate the severity of a participant's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.
Outcome measures
| Measure |
Risperidone Long-Acting Injection (RLAI)
n=37 Participants
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
|
|---|---|
|
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 96
Baseline
|
4.62 Units on a scale
Standard Deviation 0.68
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|
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 96
Change at Week 96
|
-0.89 Units on a scale
Standard Deviation 1.15
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SECONDARY outcome
Timeframe: Baseline and Week 96Population: The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, 'N'=the participants who were evaluated for this outcome measure.
GAF 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. Lower scores indicate worsening.
Outcome measures
| Measure |
Risperidone Long-Acting Injection (RLAI)
n=37 Participants
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
|
|---|---|
|
Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 96
Baseline
|
44.32 Units on a scale
Standard Deviation 12.21
|
|
Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 96
Change at Week 96
|
8.86 Units on a scale
Standard Deviation 15.80
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SECONDARY outcome
Timeframe: Baseline and Week 96Population: The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied all the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, 'N'=the participants who were evaluated for this outcome measure.
The WHOQOL-BREF is a 26-item, self-report questionnaire and short version of WHOQOL-100, consisting of 4 domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Each individual item of the WHOQOL-BREF is scored from 1=not at all to 5=completely on a response scale, which is stipulated as a 5-point ordinal scale. The scores are then transformed linearly to a scale of 0 (the worse quality of life) to 100 (the worse quality of life).
Outcome measures
| Measure |
Risperidone Long-Acting Injection (RLAI)
n=36 Participants
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
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|---|---|
|
Change From Baseline in World Health Organization (WHO)-Quality of Life (QOL) at Week 96
Baseline
|
71.22 Units on a scale
Standard Deviation 15.79
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|
Change From Baseline in World Health Organization (WHO)-Quality of Life (QOL) at Week 96
Change at Week 96
|
2.06 Units on a scale
Standard Deviation 15.85
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SECONDARY outcome
Timeframe: Baseline and Week 96Population: The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here 'N'=participants who were evaluated for this outcome measure and 'n'=participants who were evaluated for this outcome measure at given time point.
The K-WAIS is a Korean version of the Wechsler Adult Intelligence Scale-Revised (WAIS-R). It is an intelligence test that assess 3 general areas of intelligence quotients (IQ): verbal IQ, performance IQ and full-scale IQ (FSIQ). The verbal IQ includes: Digit Span, Vocabulary, and Arithmetic; performance IQ includes: Picture Arrangement and Block Design; and FSIQ is an IQ assessed by measuring an individual's overall level of general cognitive and intellectual functioning. The highest FSIQ is 160. The greater the quotient, higher the level of intelligence.
Outcome measures
| Measure |
Risperidone Long-Acting Injection (RLAI)
n=29 Participants
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
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|---|---|
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Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96
Baseline: GI, Arithmetic (n=29)
|
10.00 Intelligence quotient (IQ)
Standard Deviation 2.38
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Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96
Change at Week 96: GI, Arithmetic (n=29)
|
1.18 Intelligence quotient (IQ)
Standard Deviation 2.18
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|
Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96
Baseline: GI, Picture arrange (n=29)
|
10.10 Intelligence quotient (IQ)
Standard Deviation 2.68
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|
Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96
Change at Week 96: GI, Picture arrange (n=29)
|
2.36 Intelligence quotient (IQ)
Standard Deviation 3.07
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Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96
Baseline: GI, Block Design (n=29)
|
11.59 Intelligence quotient (IQ)
Standard Deviation 2.44
|
|
Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96
Baseline: GI, Digit Span (n=28)
|
11.39 Intelligence quotient (IQ)
Standard Deviation 2.35
|
|
Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96
Change at Week 96: GI, Digit span (n=28)
|
1.36 Intelligence quotient (IQ)
Standard Deviation 1.63
|
|
Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96
Baseline: GI, Vocabulary (n=29)
|
12.28 Intelligence quotient (IQ)
Standard Deviation 3.12
|
|
Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96
Change at Week 96: GI, Vocabulary (n=29)
|
1.18 Intelligence quotient (IQ)
Standard Deviation 1.33
|
|
Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96
Change at Week 96: GI, Block Design (n=29)
|
0.82 Intelligence quotient (IQ)
Standard Deviation 2.23
|
|
Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96
Baseline: GI, FSIQ (n=29)
|
106.07 Intelligence quotient (IQ)
Standard Deviation 15.32
|
|
Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96
Change at Week 96: GI, FSIQ (n=29)
|
10.64 Intelligence quotient (IQ)
Standard Deviation 11.98
|
SECONDARY outcome
Timeframe: Baseline and Week 96Population: The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here 'N'=participants who were evaluated for this outcome measure.
The Controlled Oral Word Associated Test is a measure of verbal fluency, which requires participants to generate words orally that begin with a given letter of the alphabet. Participants are given 1 min to name as many words as possible. Performance was calculated by the number of words generated in the 1-min period. This measure, requiring rapid and organized word retrieval, is a sensitive indicator of brain dysfunction.
Outcome measures
| Measure |
Risperidone Long-Acting Injection (RLAI)
n=28 Participants
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
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|---|---|
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Change From Baseline in NCFT: Controlled Oral Word Association Test at Week 96
Baseline: corrected response
|
10.25 Words generated per min
Standard Deviation 2.61
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|
Change From Baseline in NCFT: Controlled Oral Word Association Test at Week 96
Change at Week 96: corrected response
|
0.00 Words generated per min
Standard Deviation 1.83
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SECONDARY outcome
Timeframe: Baseline and Week 96Population: The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement.Here 'N'=participants who were evaluated for this outcome measure and 'n'=participants who were evaluated for this outcome measure at given time point.
The KAVLT is a neuropsychological assessment designed to evaluate verbal memory in participants. The KAVLT is useful in evaluating the nature and severity of memory dysfunction and to track changes in memory function over time. The test is designed as a list-learning paradigm in which the participants hears a list of 15 words, and are asked to recall as many words from the list as possible. This procedure is carried out a total of 5 times. Then a second list of 15 words is presented, allowing the participants only 1 attempt to recall. Immediately following this, the participants are asked to remember as many words as possible from the first list. KAVLT consists of 2 test conditions: Delayed Recall and Delayed Recognition. The upper limit for 'words recalled' is 15, which represents better episodic memory.
Outcome measures
| Measure |
Risperidone Long-Acting Injection (RLAI)
n=28 Participants
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
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|---|---|
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Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96
Baseline: Trial 1 (n=27)
|
9.81 Words recalled
Standard Deviation 3.50
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|
Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96
Change at Week 96: Trial 1 (n=27)
|
2.30 Words recalled
Standard Deviation 1.89
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|
Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96
Baseline: Trial 2 (n=28)
|
8.71 Words recalled
Standard Deviation 3.10
|
|
Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96
Change at Week 96: Trial 2 (n=28)
|
1.60 Words recalled
Standard Deviation 3.34
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|
Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96
Baseline: Trial 3 (n=28)
|
7.96 Words recalled
Standard Deviation 4.39
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Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96
Change at Week 96: Trial 3 (n=28)
|
2.40 Words recalled
Standard Deviation 3.10
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|
Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96
Baseline: Trial 4 (n=28)
|
8.39 Words recalled
Standard Deviation 3.92
|
|
Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96
Change at Week 96: Trial 4 (n=28)
|
0.90 Words recalled
Standard Deviation 3.63
|
|
Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96
Baseline: Trial 5 (n=28)
|
8.50 Words recalled
Standard Deviation 3.84
|
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Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96
Change at Week 96: Trial 5 (n=28)
|
1.50 Words recalled
Standard Deviation 2.22
|
|
Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96
Baseline: delayed recall (n=28)
|
8.50 Words recalled
Standard Deviation 3.96
|
|
Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96
Change at Week 96: delayed recall (n=28)
|
2.90 Words recalled
Standard Deviation 4.65
|
|
Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96
Baseline: delayed recognition (n=28)
|
9.21 Words recalled
Standard Deviation 2.63
|
|
Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96
Change at Week 96: delayed recognition (n=28)
|
1.50 Words recalled
Standard Deviation 3.72
|
SECONDARY outcome
Timeframe: Baseline and Week 96Population: The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement.
The RCFT is a neuropsychological assessment designed to evaluate visual memory in participants. The RCFT is useful in evaluating the spatial perception and visual memory. The RCFT consists of 3 test conditions: Copy, Immediate Recall and Delayed Recall. At the first step, participants are given the RCFT stimulus card, and then asked to draw the same figure. Subsequently, they are instructed to draw what they remembered. Then, after a delay of 30 min, they are required to draw the same figure once again, a score of 2 points for each drawn element (a complete straight line or a circle) remembered correctly. The total score is the sum of points scored for each correctly drawn element and it ranges from 0 to 36. The maximum score indicates excellent visual memory.
Outcome measures
| Measure |
Risperidone Long-Acting Injection (RLAI)
n=28 Participants
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
|
|---|---|
|
Change From Baseline in NCFT: Rey Kim Memory Test- Korean-Rey Complex Figure Test (K-RCFT) at Week 96
Baseline: copy
|
15.11 Units on a scale
Standard Deviation 1.40
|
|
Change From Baseline in NCFT: Rey Kim Memory Test- Korean-Rey Complex Figure Test (K-RCFT) at Week 96
Change at Week 96: copy
|
-0.10 Units on a scale
Standard Deviation 1.91
|
|
Change From Baseline in NCFT: Rey Kim Memory Test- Korean-Rey Complex Figure Test (K-RCFT) at Week 96
Baseline: immediate recall
|
8.75 Units on a scale
Standard Deviation 4.44
|
|
Change From Baseline in NCFT: Rey Kim Memory Test- Korean-Rey Complex Figure Test (K-RCFT) at Week 96
Change at Week 96: immediate recall
|
2.20 Units on a scale
Standard Deviation 3.85
|
|
Change From Baseline in NCFT: Rey Kim Memory Test- Korean-Rey Complex Figure Test (K-RCFT) at Week 96
Baseline: delayed recall
|
9.18 Units on a scale
Standard Deviation 3.43
|
|
Change From Baseline in NCFT: Rey Kim Memory Test- Korean-Rey Complex Figure Test (K-RCFT) at Week 96
Change at Week 96: delayed recall
|
1.70 Units on a scale
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Baseline and Week 96Population: The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, "N" is the number of participants evaluated for this outcome measure.
MQ was obtained by adding up the results of verbal memory and visual memory test. The memory quotient will include learning curve, memory retention, retrieval efficiency, drawing/memory consistency, verbal/visual memory consistency and intelligence/memory consistency. The highest MQ is 160, which indicates excellent memory.
Outcome measures
| Measure |
Risperidone Long-Acting Injection (RLAI)
n=28 Participants
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
|
|---|---|
|
Change From Baseline in NCFT: Memory Quotient (MQ) at Week 96
Baseline
|
93.71 MQ
Standard Deviation 15.07
|
|
Change From Baseline in NCFT: Memory Quotient (MQ) at Week 96
Change at Week 96
|
10.70 MQ
Standard Deviation 12.58
|
SECONDARY outcome
Timeframe: Baseline and Week 96Population: The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, "N" is the number of participants evaluated for this outcome measure.
TMT is attention, mental flexibility, visual search, motor function measure test. Test is divided into A and B types. Participants using a pencil or connect numbers in sequence (A-type), in turn, alternating between numbers and letters must be connected (B-type). The test measures the response time.
Outcome measures
| Measure |
Risperidone Long-Acting Injection (RLAI)
n=29 Participants
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
|
|---|---|
|
Change From Baseline in NCFT: Trail Making Test (TMT)-Time at Week 96
Baseline: Trail A-time
|
39.83 Seconds
Standard Deviation 14.95
|
|
Change From Baseline in NCFT: Trail Making Test (TMT)-Time at Week 96
Change at Week 96: Trail A-time
|
-3.18 Seconds
Standard Deviation 10.48
|
|
Change From Baseline in NCFT: Trail Making Test (TMT)-Time at Week 96
Baseline: Trail B-time
|
96.03 Seconds
Standard Deviation 33.31
|
|
Change From Baseline in NCFT: Trail Making Test (TMT)-Time at Week 96
Change at Week 96: Trail B-time
|
-16.0 Seconds
Standard Deviation 32.49
|
SECONDARY outcome
Timeframe: Baseline and Week 96Population: The ITT analysis population included all participants who received at least 1 dose of study medication, satisfied all eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, "N" is the number of participants evaluated for this outcome measure.
TMT is attention, mental flexibility, visual search, motor function measure test. Test is divided into A and B types. Participants using a pencil or connect numbers in sequence (A-type), in turn, alternating between numbers and letters must be connected (B-type). The test measures the the number of errors.
Outcome measures
| Measure |
Risperidone Long-Acting Injection (RLAI)
n=28 Participants
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
|
|---|---|
|
Change From Baseline in NCFT: TMT-Error at Week 96
Baseline: Trail A-error
|
0.11 Errors
Standard Deviation 0.31
|
|
Change From Baseline in NCFT: TMT-Error at Week 96
Change at Week 96: Trail A-error
|
0.00 Errors
Standard Deviation 0.50
|
|
Change From Baseline in NCFT: TMT-Error at Week 96
Baseline: Trail B-error
|
0.68 Errors
Standard Deviation 1.28
|
|
Change From Baseline in NCFT: TMT-Error at Week 96
Change at Week 96: Trail B-error
|
-1.11 Errors
Standard Deviation 2.42
|
SECONDARY outcome
Timeframe: Baseline and Week 96Population: The safety analysis population included all the participants who participated in the clinical trial and received at least 1 dose of RLAI. Here, 'N'=the participants who were evaluated for this outcome measure and 'n'=the participants who were evaluated for this outcome measure at given time point.
The LUNSERS is a self-report measure of antipsychotic side effects. It consists of 51 questions, 41 questions on side effects and 10 questions are of "red herrings" to validate the results. Each question is rated on a 4-point scale, where 0=not at all; and 4=very much. The total neuroleptic side effect score is the sum of the scores for the side effects items (i.e. all items excluding the red herrings). Total side effects score ranges from 0 to 164, where 0 to 40=low side effect rating, 41 to 80=medium side effect rating and greater than 81=high side effect rating.
Outcome measures
| Measure |
Risperidone Long-Acting Injection (RLAI)
n=38 Participants
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
|
|---|---|
|
Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) Score
Baseline
|
101.32 Unit on a scale
Standard Deviation 39.90
|
|
Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) Score
Week 96 (n=13)
|
76.54 Unit on a scale
Standard Deviation 17.34
|
SECONDARY outcome
Timeframe: Baseline and Week 96Population: The ITT analysis population included all the participants who received at least 1 dose of study medication, satisfied the eligibility criteria and provided at least 1 post-baseline efficacy measurement. Here, 'N'=the participants who were evaluated for this outcome measure.
The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of medication and 2) attitudes and beliefs toward neuroleptics which may influence medication 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 for each person at each time is the positive score minus the negative score.
Outcome measures
| Measure |
Risperidone Long-Acting Injection (RLAI)
n=36 Participants
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
|
|---|---|
|
Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Item Scale Score at Week 96
Baseline
|
-0.22 Units on a scale
Standard Deviation 4.92
|
|
Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Item Scale Score at Week 96
Change at Week 96
|
0.28 Units on a scale
Standard Deviation 4.51
|
SECONDARY outcome
Timeframe: Baseline and Week 96Population: The safety analysis population included all the participants who participated in the clinical trial and received at least 1 dose of risperidone long acting injection (RLAI). Here, 'N'=the participants who were evaluated for this outcome measure and 'n'=the participants who were evaluated for this outcome measure at given time point.
A scale used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.
Outcome measures
| Measure |
Risperidone Long-Acting Injection (RLAI)
n=38 Participants
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
|
|---|---|
|
Total Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) Score
Baseline
|
4.13 Units on a scale
Standard Deviation 1.12
|
|
Total Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) Score
Week 96 (n=12)
|
2.50 Units on a scale
Standard Deviation 1.45
|
Adverse Events
Risperidone Long-acting Injection (RLAI)
Serious adverse events
| Measure |
Risperidone Long-acting Injection (RLAI)
n=39 participants at risk
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
|
|---|---|
|
Psychiatric disorders
Schizophrenia
|
5.1%
2/39 • Baseline up to 2 years
|
|
Psychiatric disorders
Psychotic disorder
|
7.7%
3/39 • Baseline up to 2 years
|
|
Cardiac disorders
Cardiac disorders
|
2.6%
1/39 • Baseline up to 2 years
|
Other adverse events
| Measure |
Risperidone Long-acting Injection (RLAI)
n=39 participants at risk
The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
|
|---|---|
|
Nervous system disorders
Akathisia
|
12.8%
5/39 • Baseline up to 2 years
|
|
Nervous system disorders
Headache
|
7.7%
3/39 • Baseline up to 2 years
|
|
Gastrointestinal disorders
Oral pain
|
7.7%
3/39 • Baseline up to 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
2/39 • Baseline up to 2 years
|
|
Gastrointestinal disorders
constipation
|
5.1%
2/39 • Baseline up to 2 years
|
|
Infections and infestations
Upper respiratory tract infection
|
20.5%
8/39 • Baseline up to 2 years
|
|
Psychiatric disorders
Insomnia
|
7.7%
3/39 • Baseline up to 2 years
|
|
Eye disorders
Vision blurred
|
10.3%
4/39 • Baseline up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.1%
2/39 • Baseline up to 2 years
|
|
Reproductive system and breast disorders
Amenorrhea
|
5.1%
2/39 • Baseline up to 2 years
|
Additional Information
Medical CRA
Janssen Korea Ltd., Korea
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60