Trial Outcomes & Findings for A Comparative Study of Paliperidone Palmitate and Risperidone Long Acting Injection (LAI) in Participants With Schizophrenia (NCT NCT00604279)
NCT ID: NCT00604279
Last Updated: 2013-07-10
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 (absent) to 210 (extreme psychopathology). Higher change scores indicate worsening.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
452 participants
Primary outcome timeframe
Baseline, Day 92 or early withdrawal
Results posted on
2013-07-10
Participant Flow
Participant milestones
| Measure |
Paliperidone Palmitate
Paliperidone palmitate (R092670) suspension for intramuscular (directly into a muscle) injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
|
Risperidone Long Acting Injection (LAI)
Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
|
|---|---|---|
|
Overall Study
STARTED
|
229
|
223
|
|
Overall Study
COMPLETED
|
165
|
185
|
|
Overall Study
NOT COMPLETED
|
64
|
38
|
Reasons for withdrawal
| Measure |
Paliperidone Palmitate
Paliperidone palmitate (R092670) suspension for intramuscular (directly into a muscle) injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
|
Risperidone Long Acting Injection (LAI)
Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
22
|
9
|
|
Overall Study
Lost to Follow-up
|
9
|
14
|
|
Overall Study
Pregnancy
|
2
|
0
|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
16
|
5
|
|
Overall Study
Adverse Event
|
4
|
5
|
|
Overall Study
Other
|
8
|
4
|
Baseline Characteristics
A Comparative Study of Paliperidone Palmitate and Risperidone Long Acting Injection (LAI) in Participants With Schizophrenia
Baseline characteristics by cohort
| Measure |
Paliperidone Palmitate
n=229 Participants
Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
|
Risperidone Long Acting Injection (LAI)
n=223 Participants
Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
|
Total
n=452 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
32 years
STANDARD_DEVIATION 10.75 • n=93 Participants
|
31.5 years
STANDARD_DEVIATION 11.03 • n=4 Participants
|
31.7 years
STANDARD_DEVIATION 10.88 • n=27 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=93 Participants
|
129 Participants
n=4 Participants
|
271 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=93 Participants
|
94 Participants
n=4 Participants
|
181 Participants
n=27 Participants
|
|
Age Categorical
18-25 Years
|
87 Participants
n=93 Participants
|
92 Participants
n=4 Participants
|
179 Participants
n=27 Participants
|
|
Age Categorical
26-50 Years
|
125 Participants
n=93 Participants
|
114 Participants
n=4 Participants
|
239 Participants
n=27 Participants
|
|
Age Categorical
51-65 Years
|
17 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Age Categorical
>65 Years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age Categorical
<18 Years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 92 or early withdrawalPopulation: Per Protocol Analysis Set included participants who received at least 2 injections of study medication had minimum 5 weeks of exposure to study treatment; had baseline and at least 1 post randomization measurement for primary efficacy variable and who did not have major protocol violations.
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 (absent) to 210 (extreme psychopathology). Higher change scores indicate worsening.
Outcome measures
| Measure |
Paliperidone Palmitate
n=205 Participants
Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
|
Risperidone Long Acting Injection (LAI)
n=208 Participants
Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
|
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal
Baseline
|
82.1 Units on scale
Standard Deviation 11.95
|
84.4 Units on scale
Standard Deviation 12.69
|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal
Change at Day 92 or Early Withdrawal
|
-23.6 Units on scale
Standard Deviation 16.28
|
-26.9 Units on scale
Standard Deviation 15.43
|
SECONDARY outcome
Timeframe: Baseline, Day 92 or early withdrawalPopulation: Per Protocol Analysis Set. Here "N" (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.
This PSP assesses the degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 4, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; \<= 30, functioning so poorly as to require intensive supervision.
Outcome measures
| Measure |
Paliperidone Palmitate
n=184 Participants
Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
|
Risperidone Long Acting Injection (LAI)
n=190 Participants
Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
|
|---|---|---|
|
Change From Baseline in Personal and Social Performance (PSP) Score at Day 92 or Early Withdrawal
Baseline
|
47.8 Units on scale
Standard Deviation 12.42
|
45.3 Units on scale
Standard Deviation 11.29
|
|
Change From Baseline in Personal and Social Performance (PSP) Score at Day 92 or Early Withdrawal
Change at Day 92 or Early Withdrawal
|
16.8 Units on scale
Standard Deviation 14.76
|
18.6 Units on scale
Standard Deviation 13.92
|
SECONDARY outcome
Timeframe: Baseline, Day 92 or early withdrawalPopulation: Per Protocol Analysis Set. Here "N" (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.
The CGI-S 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 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher change scores indicate worsening.
Outcome measures
| Measure |
Paliperidone Palmitate
n=204 Participants
Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
|
Risperidone Long Acting Injection (LAI)
n=207 Participants
Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
|
|---|---|---|
|
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 92 or Early Withdrawal
Baseline
|
4.9 Units on scale
Standard Deviation 0.82
|
5.0 Units on scale
Standard Deviation 0.81
|
|
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 92 or Early Withdrawal
Change at Day 92 or Early Withdrawal
|
-1.5 Units on scale
Standard Deviation 1.24
|
-1.7 Units on scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Baseline, Day 92 or early withdrawalPopulation: Per Protocol Analysis Set.
The self-administered sleep VAS scale (0-100 millimeter \[mm\]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time).
Outcome measures
| Measure |
Paliperidone Palmitate
n=205 Participants
Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
|
Risperidone Long Acting Injection (LAI)
n=208 Participants
Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
|
|---|---|---|
|
Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal
QoS, Baseline
|
64.1 millimeter (mm)
Standard Deviation 25.40
|
66.6 millimeter (mm)
Standard Deviation 24.22
|
|
Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal
QoS, Change at Day 92 or Early Withdrawal
|
8.2 millimeter (mm)
Standard Deviation 26.95
|
10.0 millimeter (mm)
Standard Deviation 26.18
|
|
Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal
DD, Baseline
|
29.9 millimeter (mm)
Standard Deviation 25.25
|
29.6 millimeter (mm)
Standard Deviation 23.50
|
|
Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal
DD, Change at Day 92 or Early Withdrawal
|
-4.1 millimeter (mm)
Standard Deviation 27.26
|
-4.9 millimeter (mm)
Standard Deviation 24.12
|
SECONDARY outcome
Timeframe: Day 92 or early withdrawalPopulation: Per Protocol Analysis Set.
A responder is defined as a participant who improved from baseline in the PANSS total score by 30 percent or more.
Outcome measures
| Measure |
Paliperidone Palmitate
n=205 Participants
Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
|
Risperidone Long Acting Injection (LAI)
n=208 Participants
Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
|
|---|---|---|
|
Percentage of Participants Who Responded to PANSS Total Score at Day 92 or Early Withdrawal
|
70.7 Percentage of participants
25.40
|
78.4 Percentage of participants
24.22
|
Adverse Events
Paliperidone Palmitate
Serious events: 3 serious events
Other events: 115 other events
Deaths: 0 deaths
Risperidone Long Acting Injection (LAI)
Serious events: 8 serious events
Other events: 127 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paliperidone Palmitate
n=229 participants at risk
Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
|
Risperidone Long Acting Injection (LAI)
n=223 participants at risk
Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/229
|
0.45%
1/223
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/229
|
0.45%
1/223
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/229
|
0.45%
1/223
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/229
|
0.45%
1/223
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/229
|
0.45%
1/223
|
|
Nervous system disorders
Cerebral infarction
|
0.44%
1/229
|
0.00%
0/223
|
|
Nervous system disorders
Convulsion
|
0.00%
0/229
|
0.45%
1/223
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/229
|
0.45%
1/223
|
|
Psychiatric disorders
Psychiatric symptom
|
0.44%
1/229
|
0.00%
0/223
|
|
Psychiatric disorders
Schizophrenia
|
0.44%
1/229
|
0.00%
0/223
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/229
|
0.45%
1/223
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/229
|
0.45%
1/223
|
|
Social circumstances
Refusal of treatment by patient
|
0.00%
0/229
|
0.45%
1/223
|
Other adverse events
| Measure |
Paliperidone Palmitate
n=229 participants at risk
Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
|
Risperidone Long Acting Injection (LAI)
n=223 participants at risk
Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.4%
17/229
|
5.4%
12/223
|
|
Infections and infestations
Upper respiratory tract infection
|
7.9%
18/229
|
5.8%
13/223
|
|
Investigations
Blood prolactin increased
|
7.4%
17/229
|
5.4%
12/223
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
4.4%
10/229
|
7.2%
16/223
|
|
Nervous system disorders
Akathisia
|
13.1%
30/229
|
19.7%
44/223
|
|
Nervous system disorders
Bradykinesia
|
7.0%
16/229
|
4.0%
9/223
|
|
Nervous system disorders
Tremor
|
10.5%
24/229
|
17.9%
40/223
|
|
Psychiatric disorders
Anxiety
|
4.4%
10/229
|
5.8%
13/223
|
|
Psychiatric disorders
Insomnia
|
17.9%
41/229
|
13.5%
30/223
|
|
Psychiatric disorders
Restlessness
|
7.0%
16/229
|
9.9%
22/223
|
Additional Information
Local Trial Manager
Xian-Janssen Pharmaceutical Ltd
Phone: 86-10-5821 8213
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on the PI is that the sponsor can review results communications prior to publication 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 paper that incorporates confidential information requires Sponsor's written consent. PI will withhold publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER