Trial Outcomes & Findings for An Efficacy and Safety Study of Paliperidone Extended-Release (ER) Tablets in Participants With Schizophrenia (NCT NCT00566631)
NCT ID: NCT00566631
Last Updated: 2013-08-02
Results Overview
Response was defined as decrease of at least 30 percent in total Positive and Negative Syndrome Scale (PANSS) score from Baseline to endpoint of core phase (which is, Day 42 or early discontinuation). The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, \& 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 sum of all 30 PANSS items \& ranges from 30 to 210. Higher scores indicate worsening.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
294 participants
Primary outcome timeframe
Day 42 or early discontinuation
Results posted on
2013-08-02
Participant Flow
Participant milestones
| Measure |
Paliperidone Extended Release (ER)
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
|
|---|---|
|
Part 1: Core Treatment Phase
STARTED
|
294
|
|
Part 1: Core Treatment Phase
COMPLETED
|
234
|
|
Part 1: Core Treatment Phase
NOT COMPLETED
|
60
|
|
Between Treatment and Extension Phase
STARTED
|
234
|
|
Between Treatment and Extension Phase
COMPLETED
|
139
|
|
Between Treatment and Extension Phase
NOT COMPLETED
|
95
|
|
Part 2: Extension Phase
STARTED
|
139
|
|
Part 2: Extension Phase
COMPLETED
|
57
|
|
Part 2: Extension Phase
NOT COMPLETED
|
82
|
Reasons for withdrawal
| Measure |
Paliperidone Extended Release (ER)
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
|
|---|---|
|
Part 1: Core Treatment Phase
Lack of Efficacy
|
18
|
|
Part 1: Core Treatment Phase
Physician Decision
|
1
|
|
Part 1: Core Treatment Phase
Adverse Event
|
9
|
|
Part 1: Core Treatment Phase
Lost to Follow-up
|
4
|
|
Part 1: Core Treatment Phase
Withdrawal by Subject
|
26
|
|
Part 1: Core Treatment Phase
Moved to a penitentiary hospital
|
1
|
|
Part 1: Core Treatment Phase
Met exclusion criteria
|
1
|
|
Between Treatment and Extension Phase
Participants not willing to participate
|
95
|
|
Part 2: Extension Phase
Lack of Efficacy
|
25
|
|
Part 2: Extension Phase
Withdrawal by Subject
|
34
|
|
Part 2: Extension Phase
Adverse Event
|
11
|
|
Part 2: Extension Phase
Lost to Follow-up
|
6
|
|
Part 2: Extension Phase
Death
|
1
|
|
Part 2: Extension Phase
Other
|
5
|
Baseline Characteristics
An Efficacy and Safety Study of Paliperidone Extended-Release (ER) Tablets in Participants With Schizophrenia
Baseline characteristics by cohort
| Measure |
Paliperidone Extended Release (ER)
n=294 Participants
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
|
|---|---|
|
Age Continuous
|
40.3 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 42 or early discontinuationPopulation: Intent-to-treat (ITT) population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.
Response was defined as decrease of at least 30 percent in total Positive and Negative Syndrome Scale (PANSS) score from Baseline to endpoint of core phase (which is, Day 42 or early discontinuation). The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, \& 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 sum of all 30 PANSS items \& ranges from 30 to 210. Higher scores indicate worsening.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=294 Participants
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
|
|---|---|
|
Number of Participants With Treatment Response Based on Total PANSS Scale Score
|
195 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)Population: The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. "n" signifies those participants who were evaluated for this measure at given time points.
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. Final evaluation is the last post-baseline visit with data.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=294 Participants
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
|
|---|---|
|
Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Baseline (n=294)
|
100.2 Units on a scale
Standard Deviation 17.2
|
|
Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 2 (n=294)
|
-2.3 Units on a scale
Standard Deviation 5.3
|
|
Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 3 (n=287)
|
-5.8 Units on a scale
Standard Deviation 7.9
|
|
Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 4 (n=288)
|
-10.3 Units on a scale
Standard Deviation 11.3
|
|
Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 5 (n=284)
|
-13.3 Units on a scale
Standard Deviation 13.3
|
|
Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 7 (n=286)
|
-17.4 Units on a scale
Standard Deviation 15.5
|
|
Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 14 (n=276)
|
-22.3 Units on a scale
Standard Deviation 16.0
|
|
Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 28 (n=254)
|
-27.2 Units on a scale
Standard Deviation 16.6
|
|
Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 42 (n=234)
|
-32.1 Units on a scale
Standard Deviation 17.5
|
|
Change From Baseline in Total Positive and Negative Symptom Scale (PANSS) Score at Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Final Evaluation (n=294)
|
-27.5 Units on a scale
Standard Deviation 20.1
|
SECONDARY outcome
Timeframe: Baseline, Day 42 and Final Evaluation (Day 42 or early discontinuation)Population: The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.
The PANSS is a 30-item scale to assess neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms and disorganized thoughts subscale, consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement (H/E) subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28. Higher score indicates greater severity. Final evaluation is the last post-baseline visit with data.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=294 Participants
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
|
|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
Uncontrolled H/E: Change at Day 42
|
-3.8 Units on a scale
Standard Deviation 3.2
|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
Anxiety/Depression: Change at Day 42
|
-4.8 Units on a scale
Standard Deviation 3.2
|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
Positive Score: Baseline
|
28.8 Units on a scale
Standard Deviation 5.8
|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
Positive Score: Change at Day 42
|
-10.6 Units on a scale
Standard Deviation 5.9
|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
Positive Score: Change at Final Evaluation
|
-9.1 Units on a scale
Standard Deviation 6.7
|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
Negative Score: Baseline
|
24.8 Units on a scale
Standard Deviation 6.1
|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
Negative Score: Change at Day 42
|
-6.5 Units on a scale
Standard Deviation 5.1
|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
Negative Score: Change at Final Evaluation
|
-5.7 Units on a scale
Standard Deviation 5.3
|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
Disorganized Thoughts: Baseline
|
23.4 Units on a scale
Standard Deviation 4.9
|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
Disorganized Thoughts: Change at Day 42
|
-6.5 Units on a scale
Standard Deviation 4.6
|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
Disorganized Thoughts: Change at Final Evaluation
|
-5.6 Units on a scale
Standard Deviation 5.0
|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
Uncontrolled H/E: Baseline
|
10.6 Units on a scale
Standard Deviation 3.7
|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
Uncontrolled H/E: Change at Final Evaluation
|
-3.2 Units on a scale
Standard Deviation 3.8
|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
Anxiety/Depression: Baseline
|
12.5 Units on a scale
Standard Deviation 3.2
|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Day 42 and Final Evaluation (Day 42 or Early Discontinuation)
Anxiety/Depression: Change at Final Evaluation
|
-3.9 Units on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Day 2, 3, 4, 5, 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)Population: The ITT population included all participants who received at least one dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement.
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. Final evaluation is the last post-baseline visit with data.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=294 Participants
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
|
|---|---|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>40 Percent at Day 3
|
1.7 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>40 Percent at Day 4
|
6.9 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>40 Percent at Day 28
|
48.0 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>20 Percent at Day 2
|
4.4 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>20 Percent at Day 3
|
12.9 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>20 Percent at Day 4
|
29.9 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>20 percent at Day 5
|
39.4 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>20 Percent at Day 7
|
55.6 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>20 Percent at Day 14
|
72.1 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>20 Percent at Day 28
|
79.9 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>20 percent at Day 42
|
87.6 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>20 Percent at Final Evaluation
|
76.5 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>40 Percent at Day 2
|
0 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>40 Percent at Day 5
|
11.6 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>40 Percent at Day 7
|
19.6 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>40 Percent at Day 14
|
33.7 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>40 Percent at Day 42
|
59.4 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>40 Percent at Final Evaluation
|
51.4 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>50 Percent at Day 2
|
0 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>50 Percent at Day 3
|
0 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>50 Percent at Day 4
|
2.8 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>50 Percent at Day 5
|
7.4 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>50 Percent at Day 7
|
11.2 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>50 Percent at Day 14
|
18.1 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>50 Percent at Day 28
|
29.9 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>50 Percent at Day 42
|
41.5 Percentage of participants
|
|
Percentage of Participants With Treatment Response Greater Than (>) 20 Percent, 40 Percent and 50 Percent in Total Positive and Negative Syndrome Scale (PANSS) Score
Treatment Response>50 Percent at Final Evaluation
|
34.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)Population: The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluated for this measure at given time points.
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 scores indicate worsening. Final evaluation is the last post-baseline visit with data.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=289 Participants
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
|
|---|---|
|
Change From Baseline in Clinical Global Impression -Severity (CGI-S) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 14 (n=275)
|
-0.9 Units on a scale
Standard Deviation 0.8
|
|
Change From Baseline in Clinical Global Impression -Severity (CGI-S) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Baseline (n=289)
|
3.9 Units on a scale
Standard Deviation 0.7
|
|
Change From Baseline in Clinical Global Impression -Severity (CGI-S) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 7 (n=286)
|
-0.6 Units on a scale
Standard Deviation 0.7
|
|
Change From Baseline in Clinical Global Impression -Severity (CGI-S) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 28 (n=253)
|
-1.2 Units on a scale
Standard Deviation 0.9
|
|
Change From Baseline in Clinical Global Impression -Severity (CGI-S) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 42 (n=234)
|
-1.5 Units on a scale
Standard Deviation 0.9
|
|
Change From Baseline in Clinical Global Impression -Severity (CGI-S) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Final Evaluation (n=289)
|
-1.2 Units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)Population: The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluated for this measure at given time points.
The PSP assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal \& social relationships, self-care \& 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 6, very severe) in each of 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Final evaluation is the last post-baseline visit with data.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=290 Participants
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
|
|---|---|
|
Change From Baseline in Personal and Social Performance Scale (PSP) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 14 (n=276)
|
9.9 Units on a Scale
Standard Deviation 10.5
|
|
Change From Baseline in Personal and Social Performance Scale (PSP) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Baseline (n=290)
|
50.0 Units on a Scale
Standard Deviation 14.3
|
|
Change From Baseline in Personal and Social Performance Scale (PSP) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 7 (n=287)
|
6.3 Units on a Scale
Standard Deviation 9.5
|
|
Change From Baseline in Personal and Social Performance Scale (PSP) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 28 (n=254)
|
13.8 Units on a Scale
Standard Deviation 12.3
|
|
Change From Baseline in Personal and Social Performance Scale (PSP) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 42 (n=235)
|
16.1 Units on a Scale
Standard Deviation 13.9
|
|
Change From Baseline in Personal and Social Performance Scale (PSP) Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Final Evaluation (n=290)
|
13.7 Units on a Scale
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)Population: The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluated for this measure at given time points.
The sleep evaluation scale is a self-administered scale that rates quality of sleep. Participants indicate on an 11-point scale that how well they have slept within the previous 7 days, score ranged from 0 (very badly) to 10 (very well). Final evaluation is the last post-baseline visit with data.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=286 Participants
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
|
|---|---|
|
Change From Baseline in Quality of Sleep Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 42 (n=234)
|
2.6 Units on a scale
Standard Deviation 2.9
|
|
Change From Baseline in Quality of Sleep Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Final Evaluation (n=286)
|
2.1 Units on a scale
Standard Deviation 3.2
|
|
Change From Baseline in Quality of Sleep Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Baseline (n=286)
|
5.4 Units on a scale
Standard Deviation 2.8
|
|
Change From Baseline in Quality of Sleep Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 7 (n=280)
|
1.4 Units on a scale
Standard Deviation 2.9
|
|
Change From Baseline in Quality of Sleep Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 14 (n=273)
|
1.7 Units on a scale
Standard Deviation 2.9
|
|
Change From Baseline in Quality of Sleep Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 28 (n=250)
|
2.1 Units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7, 14, 28, 42 and Final Evaluation (Day 42 or early discontinuation)Population: The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluated for this measure at given time points.
The day time drowsiness evaluation scale is a self-administered scale that rates day time drowsiness. Participants indicate on an 11-point scale that how often they have felt drowsy within the previous 7 days, score ranged from 0 (not at all) to 10 (all the time). Final evaluation is the last post-baseline visit with data.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=286 Participants
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
|
|---|---|
|
Change From Baseline in Day Time Drowsiness Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Baseline (n=286)
|
3.4 Units on a scale
Standard Deviation 2.7
|
|
Change From Baseline in Day Time Drowsiness Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 7 (n=280)
|
-0.5 Units on a scale
Standard Deviation 2.5
|
|
Change From Baseline in Day Time Drowsiness Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 14 (n=273)
|
-1.0 Units on a scale
Standard Deviation 2.6
|
|
Change From Baseline in Day Time Drowsiness Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 28 (n=250)
|
-1.4 Units on a scale
Standard Deviation 2.7
|
|
Change From Baseline in Day Time Drowsiness Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 42 (n=234)
|
-1.6 Units on a scale
Standard Deviation 2.6
|
|
Change From Baseline in Day Time Drowsiness Evaluation Score at Day 7, 14, 28, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Final Evaluation (n=286)
|
-1.4 Units on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Day 42 or early discontinuationPopulation: The ITT population included all participants who received at least 1 dose of paliperidone ER and provided at least 1 post-baseline efficacy measurement. "N" (number of participants analyzed) signifies those participants who were evaluable for this measure at given time point.
Treatment satisfaction with paliperidone ER was assessed by the Investigator and participant on a 5-point scale: 1 (very good), 2 (good), 3 (reasonable), 4 (moderate) and 5 (poor), at the end of the core treatment phase (which is, Day 42 or early discontinuation) by conducting an interview.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=268 Participants
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
|
|---|---|
|
Number of Participants Satisfied With the Study Treatment
Treatment tolerability: Very good
|
84 Participants
|
|
Number of Participants Satisfied With the Study Treatment
Treatment tolerability: Good
|
124 Participants
|
|
Number of Participants Satisfied With the Study Treatment
Treatment tolerability: Reasonable
|
35 Participants
|
|
Number of Participants Satisfied With the Study Treatment
Treatment tolerability: Moderate
|
15 Participants
|
|
Number of Participants Satisfied With the Study Treatment
Treatment efficacy: Very good
|
66 Participants
|
|
Number of Participants Satisfied With the Study Treatment
Treatment efficacy: Good
|
111 Participants
|
|
Number of Participants Satisfied With the Study Treatment
Treatment efficacy: Reasonable
|
53 Participants
|
|
Number of Participants Satisfied With the Study Treatment
Treatment efficacy: Moderate
|
25 Participants
|
|
Number of Participants Satisfied With the Study Treatment
Treatment efficacy: Poor
|
13 Participants
|
|
Number of Participants Satisfied With the Study Treatment
Treatment tolerability: Poor
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)Population: Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluated for this measure at given time points.
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 and 4=severe). Final evaluation is the last post-baseline visit with data.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=290 Participants
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
|
|---|---|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 42 (n=234)
|
-0.18 Units on a scale
Standard Deviation 1.7
|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Final Evaluation (n=290)
|
-0.09 Units on a scale
Standard Deviation 1.8
|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Baseline (n=290)
|
0.59 Units on a scale
Standard Deviation 2.0
|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 7 (n=287)
|
-0.05 Units on a scale
Standard Deviation 1.2
|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 14 (n=276)
|
-0.13 Units on a scale
Standard Deviation 1.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)Population: Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluated for this measure at given time points.
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 SAS rates 10 items (including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, Glabella tap, tremor and salivation), score ranging from 0 (normal) to 4 (extreme). The SAS global score is the average score (total sum of items score divided by the number of items) and ranges between 0 and 4, where the higher score indicates more severe condition of Extrapyramidal Symptoms. Final evaluation is the last post- baseline visit with data.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=290 Participants
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
|
|---|---|
|
Change From Baseline in Simpson Angus Extrapyramidal Symptoms Rating Scale (SAS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 14 (n=276)
|
-0.00 Units on a scale
Standard Deviation 0.24
|
|
Change From Baseline in Simpson Angus Extrapyramidal Symptoms Rating Scale (SAS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 42 (n=234)
|
-0.02 Units on a scale
Standard Deviation 0.24
|
|
Change From Baseline in Simpson Angus Extrapyramidal Symptoms Rating Scale (SAS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Baseline (n=290)
|
0.16 Units on a scale
Standard Deviation 0.32
|
|
Change From Baseline in Simpson Angus Extrapyramidal Symptoms Rating Scale (SAS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 7 (n=287)
|
0.00 Units on a scale
Standard Deviation 0.23
|
|
Change From Baseline in Simpson Angus Extrapyramidal Symptoms Rating Scale (SAS) Score at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Final Evaluation (n=290)
|
0.01 Units on a scale
Standard Deviation 0.34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 7, 14, 42 and Final Evaluation (Day 42 or early discontinuation)Population: Safety population included all participants who received at least 1 dose of paliperidone ER and had at least 1 post-baseline safety assessment. "N" (number of participants analyzed) signifies those participants who were evaluable for this measure and "n" signifies those participants who were evaluated for this measure at given time points.
The BARS included an objective rating (from 0=normal to 3=constantly engaged), two subjective ratings of symptoms of akathisia, namely awareness of restlessness (ranging from 0=absence of inner restlessness to 3=awareness of intense compulsion to move) and reported distress related to restlessness (ranging from 0=no distress to 3=severe), and a global clinical rating of akathisia, ranging from 0 (absent) to 5 (severe). Global rating sub-scale score (that is, global clinical rating of akathisia) was assessed which was scored separately and is the most relevant measure of severity of akathisia. Higher scores indicates worsening akathisia. Final evaluation is the last post-baseline visit with data.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=290 Participants
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
|
|---|---|
|
Change From Baseline in Global Rating Sub-scale Score Based on Barnes Akathisia Rating Scale (BARS) at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 14 (n=276)
|
-0.01 Units on a scale
Standard Deviation 0.5
|
|
Change From Baseline in Global Rating Sub-scale Score Based on Barnes Akathisia Rating Scale (BARS) at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Final Evaluation (n=290)
|
0.03 Units on a scale
Standard Deviation 0.7
|
|
Change From Baseline in Global Rating Sub-scale Score Based on Barnes Akathisia Rating Scale (BARS) at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Baseline (n=290)
|
0.17 Units on a scale
Standard Deviation 0.5
|
|
Change From Baseline in Global Rating Sub-scale Score Based on Barnes Akathisia Rating Scale (BARS) at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 7 (n=286)
|
-0.02 Units on a scale
Standard Deviation 0.4
|
|
Change From Baseline in Global Rating Sub-scale Score Based on Barnes Akathisia Rating Scale (BARS) at Day 7, 14, 42 and Final Evaluation (Day 42 or Early Discontinuation)
Change at Day 42 (n=234)
|
-0.03 Units on a scale
Standard Deviation 0.5
|
Adverse Events
Paliperidone Extended Release (ER)
Serious events: 23 serious events
Other events: 150 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paliperidone Extended Release (ER)
n=294 participants at risk
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
|
|---|---|
|
Cardiac disorders
Tachycardia
|
0.34%
1/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.34%
1/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
General disorders
Pyrexia
|
0.34%
1/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.34%
1/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.68%
2/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Nervous system disorders
Mental impairment
|
0.34%
1/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Acute psychosis
|
0.34%
1/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Anxiety
|
0.68%
2/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Depression
|
0.34%
1/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Insomnia
|
0.34%
1/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Intentional self-injury
|
0.34%
1/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Major depression
|
0.34%
1/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Schizophrenia
|
4.1%
12/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.34%
1/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
Other adverse events
| Measure |
Paliperidone Extended Release (ER)
n=294 participants at risk
Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators' discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
|
|---|---|
|
Cardiac disorders
Tachycardia
|
8.5%
25/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Constipation
|
3.1%
9/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
13/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Nervous system disorders
Akathisia
|
4.4%
13/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Nervous system disorders
Extrapyramidal disorder
|
6.1%
18/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Nervous system disorders
Headache
|
7.5%
22/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Agitation
|
3.4%
10/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Anxiety
|
4.8%
14/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Insomnia
|
23.1%
68/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Restlessness
|
3.4%
10/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Psychiatric disorders
Sleep disorder
|
3.1%
9/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
|
Vascular disorders
Hypertension
|
4.4%
13/294 • 6 weeks in the core treatment phase
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable \& unintended sign/abnormal finding, symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
|
Additional Information
EMEA Therapeutic Area Leader CNS
Janssen-Cilag Germany
Phone: +492137955153
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60