Trial Outcomes & Findings for Safety and Efficacy Study of Paliperidone Extended Release (ER) Among Thai Schizophrenia Participants (NCT NCT01387542)
NCT ID: NCT01387542
Last Updated: 2013-03-05
Results Overview
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 .
COMPLETED
PHASE4
40 participants
Baseline, Week 10
2013-03-05
Participant Flow
Participant milestones
| Measure |
Paliperidone Extended Release (ER)
Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
Treated
|
38
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Paliperidone Extended Release (ER)
Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Changed diagnosis
|
1
|
|
Overall Study
Insufficient response
|
1
|
|
Overall Study
Non-compliant
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Paliperidone Extended Release (ER) Among Thai Schizophrenia Participants
Baseline characteristics by cohort
| Measure |
Paliperidone Extended Release (ER)
n=38 Participants
Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
|
|---|---|
|
Age Continuous
|
41.13 Years
STANDARD_DEVIATION 12.314 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 10Population: Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.
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 .
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=38 Participants
Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
|
|---|---|
|
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10
Baseline
|
3.55 Units on a scale
Standard Deviation 1.155
|
|
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10
Change at Week 10
|
0.82 Units on a scale
Standard Deviation 1.036
|
PRIMARY outcome
Timeframe: Baseline, Week 2Population: Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.
The PSP scale assesses 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. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have 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.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=38 Participants
Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
|
|---|---|
|
Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2
Baseline
|
58.95 Units on a scale
Standard Deviation 15.710
|
|
Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2
Change at Week 2
|
-4.289 Units on a scale
Standard Deviation 9.647
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.
The PSP scale assesses 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. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have 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.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=38 Participants
Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
|
|---|---|
|
Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 6
|
-7.053 Units on a scale
Standard Deviation 11.463
|
PRIMARY outcome
Timeframe: Baseline, Week 10Population: Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.
The PSP scale assesses 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. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have 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.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=38 Participants
Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
|
|---|---|
|
Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 10
|
-9.868 Units on a scale
Standard Deviation 14.640
|
Adverse Events
Paliperidone Extended Release (ER)
Serious adverse events
| Measure |
Paliperidone Extended Release (ER)
n=40 participants at risk
Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
|
|---|---|
|
Psychiatric disorders
Mania
|
2.5%
1/40 • Number of events 1 • 10 weeks
|
|
Psychiatric disorders
Elevated mood
|
2.5%
1/40 • Number of events 1 • 10 weeks
|
Other adverse events
| Measure |
Paliperidone Extended Release (ER)
n=40 participants at risk
Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
|
|---|---|
|
Nervous system disorders
Drowsiness
|
15.0%
6/40 • 10 weeks
|
|
Nervous system disorders
Headache
|
15.0%
6/40 • 10 weeks
|
|
Psychiatric disorders
Insomnia
|
12.5%
5/40 • 10 weeks
|
|
Nervous system disorders
Extrapyramidal disorder
|
7.5%
3/40 • 10 weeks
|
|
Gastrointestinal disorders
Nausea
|
7.5%
3/40 • 10 weeks
|
|
Gastrointestinal disorders
Constipation
|
5.0%
2/40 • 10 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
2/40 • 10 weeks
|
|
Vascular disorders
Hypotension
|
5.0%
2/40 • 10 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.0%
2/40 • 10 weeks
|
|
Cardiac disorders
Palpitation
|
5.0%
2/40 • 10 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
2/40 • 10 weeks
|
Additional Information
Medical Affairs Director
Janssen-Cilag Ltd.: 106 Moo 4 Lad Krabang Industrial Estate, Chalongkrung Rd., Lamplatew, Lad Krabang, Bangkok 10520
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