Trial Outcomes & Findings for A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia (NCT NCT01577160)
NCT ID: NCT01577160
Last Updated: 2014-01-14
Results Overview
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Responders were defined as participants evaluated as "1: very much improved" or "2: much improved" on the CGI-I scale at Week 12.
COMPLETED
PHASE4
353 participants
Week 12
2014-01-14
Participant Flow
Participant milestones
| Measure |
Paliperidone ER
Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's Clinical Global Impression - Improvement (CGI-I) score.
|
|---|---|
|
Overall Study
STARTED
|
353
|
|
Overall Study
COMPLETED
|
255
|
|
Overall Study
NOT COMPLETED
|
98
|
Reasons for withdrawal
| Measure |
Paliperidone ER
Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's Clinical Global Impression - Improvement (CGI-I) score.
|
|---|---|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Lack of Efficacy
|
15
|
|
Overall Study
Lost to Follow-up
|
40
|
|
Overall Study
Withdrawal by Subject
|
18
|
|
Overall Study
Subject Uncooperative
|
7
|
|
Overall Study
Other
|
9
|
Baseline Characteristics
A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia
Baseline characteristics by cohort
| Measure |
Paliperidone ER
n=353 Participants
Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score.
|
|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
221 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants evaluable for this measure.
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Responders were defined as participants evaluated as "1: very much improved" or "2: much improved" on the CGI-I scale at Week 12.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=255 Participants
Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score.
|
|---|---|
|
Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale
|
21.6 percentage of participants
Interval 16.68 to 27.13
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.
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=331 Participants
Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score.
|
|---|---|
|
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12
Baseline (n=331)
|
5.0 units on a scale
Standard Deviation 0.8
|
|
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12
Change at Week 12 (n=255)
|
-1.4 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Week 12Population: ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants evaluable for this measure.
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=255 Participants
Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score.
|
|---|---|
|
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
Very much improved
|
3 participants
0.9
|
|
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
Much improved
|
52 participants
|
|
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
Minimally improved
|
119 participants
|
|
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
No change
|
67 participants
|
|
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
Minimally worse
|
10 participants
|
|
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
Much worse
|
2 participants
|
|
Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score
Very much worse
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.
The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=331 Participants
Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score.
|
|---|---|
|
Change From Baseline in Personal and Social Performance (PSP) Score at Week 12
Baseline (n=331)
|
42.6 units on a scale
Standard Deviation 14.9
|
|
Change From Baseline in Personal and Social Performance (PSP) Score at Week 12
Change at Week 12 (n=267)
|
14.3 units on a scale
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.
The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response (SR). A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive SR; a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=331 Participants
Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score.
|
|---|---|
|
Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12
Baseline (n=331)
|
2.5 units on a scale
Standard Deviation 4.6
|
|
Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12
Change at Week 12 (n=267)
|
1.0 units on a scale
Standard Deviation 4.9
|
Adverse Events
Paliperidone ER
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paliperidone ER
n=353 participants at risk
Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
11.3%
40/353
|
|
General disorders
Pyrexia
|
2.3%
8/353
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
18/353
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.1%
18/353
|
|
Injury, poisoning and procedural complications
Wound
|
2.5%
9/353
|
|
Nervous system disorders
Extrapyramidal Disorder
|
9.6%
34/353
|
|
Nervous system disorders
Headache
|
2.5%
9/353
|
|
Psychiatric disorders
Anxiety
|
7.1%
25/353
|
|
Psychiatric disorders
Delusion
|
2.3%
8/353
|
|
Psychiatric disorders
Depression
|
2.5%
9/353
|
|
Psychiatric disorders
Insomnia
|
15.9%
56/353
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
13/353
|
Additional Information
Medical Director
Janssen Research & Development
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60