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An Efficacy Study of Paliperidone for the Prevention of Relapse in Participants With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01662310
Recruitment Status : Completed
First Posted : August 10, 2012
Results First Posted : June 6, 2014
Last Update Posted : September 29, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Paliperidone
Drug: Placebo
Enrollment 201
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone: Run-in or Stabilization Phase Paliperidone: Double Blind (DB) Phase Placebo: DB Phase Paliperidone DB/Paliperidone Open-label (OL) Extension Phase Placebo DB/Paliperidone OL Extension Phase
Hide Arm/Group Description Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 milligram per day (mg/day) after 5 days based on Investigator's discretion, up to maximum of 12 mg/day. Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study. Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study. Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg. Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
Period Title: Run-In or Stabilization Phase
Started 201 0 0 0 0
Completed 136 0 0 0 0
Not Completed 65 0 0 0 0
Reason Not Completed
Adverse Event             11             0             0             0             0
Lack of Efficacy             9             0             0             0             0
Lost to Follow-up             4             0             0             0             0
Protocol Violation             15             0             0             0             0
Withdrawal by Subject             25             0             0             0             0
Other             1             0             0             0             0
Period Title: Double-Blind Phase
Started 0 65 71 0 0
Treated 0 64 71 0 0
Completed 0 50 66 0 0
Not Completed 0 15 5 0 0
Reason Not Completed
Adverse Event             0             0             1             0             0
Lost to Follow-up             0             3             0             0             0
Pregnancy             0             2             0             0             0
Withdrawal by Subject             0             9             3             0             0
Other             0             0             1             0             0
Randomized but not treated             0             1             0             0             0
Period Title: Open-Label Extension Phase
Started 0 0 0 47 59
Completed 0 0 0 36 49
Not Completed 0 0 0 11 10
Reason Not Completed
Adverse Event             0             0             0             3             0
Death             0             0             0             1             0
Lack of Efficacy             0             0             0             2             2
Lost to Follow-up             0             0             0             2             1
Pregnancy             0             0             0             1             0
Withdrawal by Subject             0             0             0             2             7
Arm/Group Title Entire Study Population
Hide Arm/Group Description All the participants who were enrolled.
Overall Number of Baseline Participants 201
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 201 participants
31.3  (10.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants
Female
110
  54.7%
Male
91
  45.3%
1.Primary Outcome
Title Double Blind (DB) Phase: Median Time to Relapse
Hide Description A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed ongoing safety monitoring during double-blind treatment and conducted the interim analysis after 61 relapse events had taken place.
Time Frame DB Baseline (Day 1 of Week 15) up to interim analysis data cut-off (24 August 2012) (Approximately 1 year)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication up to interim analysis cut-off date (24-Aug-2012). "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone: Double Blind (DB) Phase Placebo: DB Phase
Hide Arm/Group Description:
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
Overall Number of Participants Analyzed 59 65
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
49.0
(22.0 to 77.0)
[1]
Median time was not reached as data was not matured at the time of the analysis, hence no data could be reported.
2.Secondary Outcome
Title Run-In and Stabilization Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 14
Hide Description 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.
Time Frame Baseline and Week 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. "n" signifies those participants who were evaluated for this measure at the specified time point. Last observation carried forward (LOCF) method was used to impute missing values.
Arm/Group Title Paliperidone: Run-in or Stabilization Phase
Hide Arm/Group Description:
Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
Overall Number of Participants Analyzed 201
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=201) 89.5  (12.48)
Change at Week 14 (n=200) -30.8  (18.55)
3.Secondary Outcome
Title Double Blind (DB) Phase: Change From DB Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at DB Endpoint
Hide Description 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. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
Time Frame DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. LOCF method was used to impute missing values.
Arm/Group Title Paliperidone: Double Blind (DB) Phase Placebo: DB Phase
Hide Arm/Group Description:
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
Overall Number of Participants Analyzed 64 71
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 53.4  (9.71) 51.5  (9.50)
Change at DB endpoint 2.0  (12.67) 16.9  (16.16)
4.Secondary Outcome
Title Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
Hide Description The CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.
Time Frame Baseline and Week 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. "n" signifies those participants who were evaluated for this measure at the specified time point.
Arm/Group Title Paliperidone: Run-in or Stabilization Phase
Hide Arm/Group Description:
Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
Overall Number of Participants Analyzed 201
Measure Type: Number
Unit of Measure: Participants
Not ill: Baseline (n=201) 0
Not ill: Week 14 (n= 135) 2
Very Mild: Baseline (n= 201) 0
Very Mild: Week 14 (n= 135) 37
Mild: Baseline (n= 201) 3
Mild: Week 14 (n= 135) 65
Moderate: Baseline (n= 201) 41
Moderate: Week 14 (n= 135) 27
Marked: Baseline (n= 201) 91
Marked: Week 14 (n= 135) 4
Severe: Baseline (n= 201) 66
Severe: Week 14 (n= 135) 0
Extremely Severe: Baseline (n= 201) 0
Extremely Severe: Week 14 (n= 135) 0
5.Secondary Outcome
Title Double Blind (DB) Phase: Change From DB Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at DB Endpoint
Hide Description CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
Time Frame DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication.
Arm/Group Title Paliperidone: Double Blind (DB) Phase Placebo: DB Phase
Hide Arm/Group Description:
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
Overall Number of Participants Analyzed 64 71
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 3.0  (0.88) 2.9  (0.70)
Change at DB endpoint 0.1  (0.91) 1.1  (1.11)
6.Secondary Outcome
Title Run-In and Stabilization Phase: Change From Baseline in Personal and Social Performance (PSP) Scale Total Score at Week 14
Hide Description 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). Percentage of participants achieving improvement in PSP score by at least one category was reported.
Time Frame Baseline and Week 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. "n" signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values.
Arm/Group Title Paliperidone: Run-in or Stabilization Phase
Hide Arm/Group Description:
Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
Overall Number of Participants Analyzed 201
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=201) 43.6  (13.96)
Change at Week 14 (n=200) 20.9  (17.55)
7.Secondary Outcome
Title Double Blind (DB) Phase: Change From DB Baseline in Personal and Social Performance (PSP) Scale Total Score at DB Endpoint
Hide Description 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). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
Time Frame DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication.
Arm/Group Title Paliperidone: Double Blind (DB) Phase Placebo: DB Phase
Hide Arm/Group Description:
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
Overall Number of Participants Analyzed 64 71
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 69.3  (11.17) 69.9  (9.37)
Change at DB Endpoint -2.9  (12.87) -10.7  (14.99)
8.Secondary Outcome
Title Run-In and Stabilization Phase: Change From Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at Week 14
Hide Description Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: "very badly" to 100: "very well").
Time Frame Baseline and Week 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. "n" signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values.
Arm/Group Title Paliperidone: Run-in or Stabilization Phase
Hide Arm/Group Description:
Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
Overall Number of Participants Analyzed 201
Mean (Standard Deviation)
Unit of Measure: Millimeter (mm)
Baseline (n=201) 63.4  (24.60)
Change at Week 14 (n=192) 12.1  (29.13)
9.Secondary Outcome
Title Double Blind (DB) Phase: Change From DB Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at DB Endpoint
Hide Description Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: "very badly" to 100: "very well"). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
Time Frame DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. "n" signifies those participants who were evaluated for this measure at the specified time point.
Arm/Group Title Paliperidone: Double Blind (DB) Phase Placebo: DB Phase
Hide Arm/Group Description:
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
Overall Number of Participants Analyzed 64 71
Mean (Standard Deviation)
Unit of Measure: Millimeter (mm)
Baseline (n= 64, 71) 77.5  (20.45) 81.9  (14.82)
Change at DB Endpoint (n= 60, 69) -3.8  (20.02) -22.4  (27.88)
10.Secondary Outcome
Title Run-In and Stabilization Phase: Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at Week 14
Hide Description Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: "very badly" to 100: "very well").
Time Frame Baseline and Week 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. "n" signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values.
Arm/Group Title Paliperidone: Run-in or Stabilization Phase
Hide Arm/Group Description:
Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
Overall Number of Participants Analyzed 201
Mean (Standard Deviation)
Unit of Measure: Millimeter (mm)
Baseline (n=201) 32.8  (27.03)
Change at Week 14 (n=192) -7.3  (33.73)
11.Secondary Outcome
Title Double Blind (DB) Phase: Change From DB Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at DB Endpoint
Hide Description Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: "very badly" to 100: "very well"). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
Time Frame DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. "n" signifies those participants who were evaluated for this measure at the specified time point.
Arm/Group Title Paliperidone: Double Blind (DB) Phase Placebo: DB Phase
Hide Arm/Group Description:
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
Overall Number of Participants Analyzed 64 71
Mean (Standard Deviation)
Unit of Measure: Millimeter (mm)
Baseline (n= 64, 71) 22.9  (24.24) 24.4  (22.93)
Change at DB Endpoint (n= 60, 69) 3.1  (23.18) 1.2  (28.50)
12.Secondary Outcome
Title Double Blind (DB) Phase: Median Time to Relapse (Final Analysis)
Hide Description A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed final analysis at the end of double-blind treatment (09 November 2012).
Time Frame DB Baseline (Day 1 of Week 15) up to study completion (09 November 2012) (Approximately 1 year)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication up to final analysis cut-off date (09-Nov-2012).
Arm/Group Title Paliperidone: Double Blind (DB) Phase Placebo: DB Phase
Hide Arm/Group Description:
Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
Overall Number of Participants Analyzed 64 71
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
52.0
(29.0 to 77.0)
[1]
Median time was not reached as data was not matured at the time of the analysis, hence no data could be reported.
13.Secondary Outcome
Title Open-label Extension (OLE) Phase: Change From OLE Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at OLE Endpoint
Hide Description 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. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).
Time Frame OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone DB/Paliperidone Open-label (OL) Extension Phase Placebo DB/Paliperidone OL Extension Phase
Hide Arm/Group Description:
Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
Overall Number of Participants Analyzed 46 59
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 56.5  (14.86) 67.2  (14.67)
Change at OLE endpoint -3.9  (11.30) -15.4  (12.41)
14.Secondary Outcome
Title Open-label Extension (OLE) Phase: Change From OLE Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at OLE Endpoint
Hide Description CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).
Time Frame OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone DB/Paliperidone Open-label (OL) Extension Phase Placebo DB/Paliperidone OL Extension Phase
Hide Arm/Group Description:
Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
Overall Number of Participants Analyzed 46 59
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 3.1  (1.02) 3.9  (0.98)
Change at OLE endpoint -0.2  (0.78) -0.9  (0.97)
15.Secondary Outcome
Title Open-label Extension (OLE) Phase: Change From OLE Baseline in Personal and Social Performance (PSP) Scale Total Score at OLE Endpoint
Hide Description 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). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).
Time Frame OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)
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Hide Analysis Population Description
The ITT OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
Arm/Group Title Paliperidone DB/Paliperidone Open-label (OL) Extension Phase Placebo DB/Paliperidone OL Extension Phase
Hide Arm/Group Description:
Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
Overall Number of Participants Analyzed 46 59
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 66.8  (15.68) 60.6  (15.63)
Change at OLE endpoint 10.88  (3.1) 10.7  (14.01)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety analysis set included all the participants who were randomized into the double-blind phase and received at least 1 dose of double-blind medication.
 
Arm/Group Title Paliperidone: Run-in or Stabilization Phase Paliperidone: Double Blind (DB) Phase Placebo: DB Phase Paliperidone DB/Paliperidone Open-label (OL) Extension Phase Placebo DB/Paliperidone OL Extension Phase
Hide Arm/Group Description Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day. Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study. Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study. Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg. Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
All-Cause Mortality
Paliperidone: Run-in or Stabilization Phase Paliperidone: Double Blind (DB) Phase Placebo: DB Phase Paliperidone DB/Paliperidone Open-label (OL) Extension Phase Placebo DB/Paliperidone OL Extension Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone: Run-in or Stabilization Phase Paliperidone: Double Blind (DB) Phase Placebo: DB Phase Paliperidone DB/Paliperidone Open-label (OL) Extension Phase Placebo DB/Paliperidone OL Extension Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/201 (1.00%)   2/64 (3.13%)   8/71 (11.27%)   2/47 (4.26%)   0/59 (0.00%) 
Psychiatric disorders           
Aggression * 1  0/201 (0.00%)  0/64 (0.00%)  1/71 (1.41%)  0/47 (0.00%)  0/59 (0.00%) 
Completed Suicide * 1  0/201 (0.00%)  0/64 (0.00%)  1/71 (1.41%)  1/47 (2.13%)  0/59 (0.00%) 
Hallucination, Auditory * 1  0/201 (0.00%)  0/64 (0.00%)  1/71 (1.41%)  0/47 (0.00%)  0/59 (0.00%) 
Psychotic Disorder * 1  1/201 (0.50%)  0/64 (0.00%)  0/71 (0.00%)  0/47 (0.00%)  0/59 (0.00%) 
Schizophrenia * 1  1/201 (0.50%)  1/64 (1.56%)  5/71 (7.04%)  1/47 (2.13%)  0/59 (0.00%) 
Suicide Attempt * 1  0/201 (0.00%)  1/64 (1.56%)  0/71 (0.00%)  0/47 (0.00%)  0/59 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Paliperidone: Run-in or Stabilization Phase Paliperidone: Double Blind (DB) Phase Placebo: DB Phase Paliperidone DB/Paliperidone Open-label (OL) Extension Phase Placebo DB/Paliperidone OL Extension Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   141/201 (70.15%)   12/64 (18.75%)   12/71 (16.90%)   6/47 (12.77%)   14/59 (23.73%) 
Cardiac disorders           
Tachycardia * 1  12/201 (5.97%)  0/64 (0.00%)  1/71 (1.41%)  0/47 (0.00%)  0/59 (0.00%) 
Ear and labyrinth disorders           
Vertigo * 1  19/201 (9.45%)  1/64 (1.56%)  1/71 (1.41%)  0/47 (0.00%)  0/59 (0.00%) 
Eye disorders           
Vision Blurred * 1  13/201 (6.47%)  1/64 (1.56%)  0/71 (0.00%)  0/47 (0.00%)  0/59 (0.00%) 
Gastrointestinal disorders           
Constipation * 1  19/201 (9.45%)  1/64 (1.56%)  0/71 (0.00%)  2/47 (4.26%)  2/59 (3.39%) 
Nausea * 1  12/201 (5.97%)  2/64 (3.13%)  1/71 (1.41%)  0/47 (0.00%)  0/59 (0.00%) 
Infections and infestations           
Nasopharyngitis * 1  17/201 (8.46%)  0/64 (0.00%)  2/71 (2.82%)  1/47 (2.13%)  3/59 (5.08%) 
Upper Respiratory Tract Infection * 1  12/201 (5.97%)  1/64 (1.56%)  1/71 (1.41%)  1/47 (2.13%)  1/59 (1.69%) 
Investigations           
Weight Increased * 1  13/201 (6.47%)  1/64 (1.56%)  1/71 (1.41%)  0/47 (0.00%)  2/59 (3.39%) 
Nervous system disorders           
Akathisia * 1  52/201 (25.87%)  3/64 (4.69%)  0/71 (0.00%)  1/47 (2.13%)  3/59 (5.08%) 
Dyskinesia * 1  11/201 (5.47%)  0/64 (0.00%)  1/71 (1.41%)  0/47 (0.00%)  0/59 (0.00%) 
Dystonia * 1  11/201 (5.47%)  0/64 (0.00%)  0/71 (0.00%)  0/47 (0.00%)  1/59 (1.69%) 
Headache * 1  11/201 (5.47%)  1/64 (1.56%)  0/71 (0.00%)  1/47 (2.13%)  1/59 (1.69%) 
Hypertonia * 1  14/201 (6.97%)  0/64 (0.00%)  0/71 (0.00%)  0/47 (0.00%)  0/59 (0.00%) 
Somnolence * 1  19/201 (9.45%)  0/64 (0.00%)  0/71 (0.00%)  1/47 (2.13%)  3/59 (5.08%) 
Tremor * 1  24/201 (11.94%)  2/64 (3.13%)  0/71 (0.00%)  0/47 (0.00%)  0/59 (0.00%) 
Psychiatric disorders           
Insomnia * 1  21/201 (10.45%)  1/64 (1.56%)  6/71 (8.45%)  1/47 (2.13%)  1/59 (1.69%) 
Restlessness * 1  12/201 (5.97%)  1/64 (1.56%)  0/71 (0.00%)  0/47 (0.00%)  2/59 (3.39%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
Independent Data Monitoring Committee (IDMC) conducted an interim analysis after 61st relapse in double-blind (DB) phase and DB phase completed on 09-Nov-2012 based on positive results of interim analysis.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If an Investigator wishes to publish information from study, a copy of the manuscript must be provided to the Sponsor for review at least 60 days before submission for publication or presentation. If requested by the Sponsor, investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application. Investigators will not publish data derived from individual site until Sponsor confirms there will be no multi-center study publication.
Results Point of Contact
Name/Title: Senior Director Clinical Leader
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01662310     History of Changes
Other Study ID Numbers: CR100427
R076477-SCH-3041 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: March 29, 2012
First Posted: August 10, 2012
Results First Submitted: April 30, 2014
Results First Posted: June 6, 2014
Last Update Posted: September 29, 2014