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A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform (DREaM)

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ClinicalTrials.gov Identifier: NCT02431702
Recruitment Status : Completed
First Posted : May 1, 2015
Results First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Schizophrenia
Psychotic Disorders
Interventions Drug: Aripiprazole
Drug: Haloperidol
Drug: Olanzapine
Drug: Oral Paliperidone ER
Drug: Perphenazine
Drug: Quetiapine
Drug: Oral Risperidone
Drug: Paliperidone Palmitate Injection (PP1M)
Drug: Paliperidone Palmitate Injection (PP3M)
Enrollment 337
Recruitment Details A total of 337 participants were enrolled out of which 273 were randomized and received study medication while 64 did not and served as healthy controls. Healthy controls underwent MRI assessments as controls for the MRI machine calibration. They did not receive study medication and no safety or efficacy data were collected.
Pre-assignment Details To ensure that the total number of participants equal 337, another group is created called "Healthy Controls" to the table below and their completion status is reported in Part 1 and not in other parts.
Arm/Group Title Part 1-Run-in: Oral Antipsychotics (OAP) Part 2-Paliperidone Palmitate (PP) Part 2-OAP Part 3-PP to PP (Extended Disease Progression [EDP] and Disease Modification) Part 3- OAP to PP (or Delayed-Start PP) (Disease Modification) Part 3-OAP to OAP (EDP and Disease Modification) Healthy Controls
Hide Arm/Group Description All participants received paliperidone extended Release (ER) 1.5 to 12 milligrams (mg) or risperidone 1 to 6 mg once daily orally for 2 months. Participants who tolerated paliperidone ER/risperidone but found it inadequately efficacious after treatment for an adequate duration at an adequate dosage (per clinical judgment), may be switched to another protocol-specified OAP at the discretion of the investigator. Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2). Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3). Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive PP treatment for additional 9 months (up to Day 260). PP treatment includes PP1M or PP3M. Participants subsequently switched to PP3M following a minimum of 5 injections of PP1M. Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3). Participants did not receive any study medication and did not fall into any of the 3 parts of the study. For reporting purposes, the completion of the Healthy Controls were entered in Part 1 and not in the other parts.
Period Title: Part 1: 2-Month Oral Run-in Phase
Started 273 0 0 0 0 0 64
Completed 239 0 0 0 0 0 32
Not Completed 34 0 0 0 0 0 32
Reason Not Completed
Adverse Event             7             0             0             0             0             0             0
Lost to Follow-up             11             0             0             0             0             0             23
Withdrawal of Consent             9             0             0             0             0             0             6
Other             5             0             0             0             0             0             3
Does not Tolerate Paliperidone ER             2             0             0             0             0             0             0
Period Title: Part 2: 9Month Disease Progression Phase
Started 0 78 [1] 157 [1] 0 0 0 0
Completed 0 52 128 0 0 0 0
Not Completed 0 26 29 0 0 0 0
Reason Not Completed
Adverse Event             0             5             1             0             0             0             0
Lost to Follow-up             0             6             13             0             0             0             0
Withdrawal by Subject             0             11             8             0             0             0             0
Assigned PP, but required OAP             0             2             0             0             0             0             0
Other             0             2             2             0             0             0             0
Assigned OAP, but required PP             0             0             5             0             0             0             0
[1]
Participants who completed Part 1 and were eligible to be randomized in this group.
Period Title: Part 3: 9 Month of Additional Treatment
Started 0 0 0 49 [1] 57 [2] 63 [2] 0
Completed 0 0 0 40 47 46 0
Not Completed 0 0 0 9 10 17 0
Reason Not Completed
Adverse Event             0             0             0             2             3             0             0
Lost to Follow-up             0             0             0             1             0             5             0
Withdrawal by Subject             0             0             0             5             6             6             0
Other             0             0             0             1             1             6             0
[1]
Participants who completed Part 2 and were eligible to continue treatment in this group.
[2]
Participants who completed Part 2 and were eligible to be re-randomized in this group.
Arm/Group Title Part 1-Oral Antipsychotics (OAP)
Hide Arm/Group Description All participants received paliperidone extended Release (ER) 1.5 to 12 milligrams (mg) or risperidone 1 to 6 mg once daily orally for 2 months. Participants who tolerated paliperidone ER/risperidone but found it inadequately efficacious after treatment for an adequate duration at an adequate dosage (per clinical judgment), may be switched to another protocol-specified OAP at the discretion of the investigator.
Overall Number of Baseline Participants 273
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 273 participants
23.2  (4.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 273 participants
Female
60
  22.0%
Male
213
  78.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 273 participants
Hispanic or Latino
95
  34.8%
Not Hispanic or Latino
173
  63.4%
Unknown or Not Reported
5
   1.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 273 participants
American Indian or Alaska Native
0
   0.0%
Asian
17
   6.2%
Black or African American
91
  33.3%
Native Hawaiian or Other Pacific Islander
2
   0.7%
White
124
  45.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Other
39
  14.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 273 participants
BRAZIL
40
  14.7%
MEXICO
26
   9.5%
UNITED STATES
207
  75.8%
1.Primary Outcome
Title Part-2 (Disease Progression): Time to First Treatment Failure
Hide Description Treatment failure is defined as the time from participant's randomization to first treatment failure, which was a composite endpoint consisting of any of the following: 1) Psychiatric hospitalization due to worsening symptoms; 2) Any deliberate self-injury, suicidal ideation or behavior, homicidal ideation or violent behavior that is clinically significant and needs immediate intervention as determined by the study physician; 3) New arrest/incarceration; 4) Discontinuation of antipsychotic treatment due to inadequate efficacy as determined by the study physician; 5) Discontinuation of antipsychotic treatment due to safety or tolerability as determined by the study physician; 6) Treatment supplementation with another antipsychotic due to inadequate efficacy as determined by the study physician; 7) Increase in the level of psychiatric services in order to prevent imminent psychiatric hospitalization as determined by the study physician.
Time Frame From Day 1 up to 9 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Part 2 Intent-to-Treat (ITT) analysis set included all randomized participants who received at least one dose of study medication (or any portion of the dose) in Part 2, regardless of their compliance with the protocol.
Arm/Group Title Part-2: Paliperidone Palmitate (PP) Part-2: OAP
Hide Arm/Group Description:
Participants who completed part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants were subsequently switched to PP3M (paliperidone palmitate three-monthly injection) following a minimum of 5 injections of PP1M.
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were re-randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2).
Overall Number of Participants Analyzed 78 157
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(263.0 to NA)
NA [2] 
(NA to NA)
[1]
Here, NA signifies median or upper limit of CI was not estimable due to less than 50% of participants experienced an event..
[2]
Here, NA signifies that median or upper/lower limit of CI was not estimable due to less than 50% of participants experienced an event.
2.Primary Outcome
Title Part 3 (Extended Disease Progression [EDP]): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score
Hide Description The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score and composites scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning.
Time Frame Baseline and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Part 3 ITT analysis set included all randomized participants who received at least one dose of study medication (or any portion of the dose) in Part 3, regardless of their compliance with the protocol. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Part 3-PP to PP Part 3-OAP to OAP
Hide Arm/Group Description:
Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
Overall Number of Participants Analyzed 39 44
Mean (Standard Error)
Unit of Measure: T-score
1.6  (1.19) 3.2  (1.11)
3.Primary Outcome
Title Part 3 (Disease Modification): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score
Hide Description The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score and composites scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning.
Time Frame Baseline and Day 260
Hide Outcome Measure Data
Hide Analysis Population Description
Part 3 ITT analysis set included all randomized participants who received at least one dose of study medication (or any portion of the dose) in Part 3, regardless of their compliance with the protocol.
Arm/Group Title Part 3- PP to PP Part 3- OAP to PP (or Delayed-Start PP) Part 3-OAP to OAP
Hide Arm/Group Description:
Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive PP treatment for additional 9 months (up to Day 260). PP treatment includes PP1M and PP3M. Participants subsequently switched to PP3M following a minimum of 5 injections of PP1M.
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
Overall Number of Participants Analyzed 49 57 63
Mean (Standard Error)
Unit of Measure: T-score
-0.7  (1.02) -0.2  (0.95) 0.5  (0.96)
4.Secondary Outcome
Title Part 2 (Disease Progression): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score
Hide Description The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score and composites scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning.
Time Frame Baseline and Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 2 ITT analysis set. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Part-2: Paliperidone Palmitate (PP) Part-2: OAP
Hide Arm/Group Description:
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants were subsequently switched to PP3M (paliperidone palmitate three-monthly injection) following a minimum of 5 injections of PP1M.
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were re-randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2).
Overall Number of Participants Analyzed 52 118
Least Squares Mean (Standard Error)
Unit of Measure: T-score
2.0  (1.01) 2.8  (0.73)
5.Secondary Outcome
Title Part 2 (Disease Progression): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score
Hide Description The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Each domain was assessed on a 6-point scale, from 1 (absent) to 6 (very severe) (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe). PSP total score was calculated as sum of all the domain scores and ranges from 1 to 100. 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. Higher score indicate better performance.
Time Frame Baseline and Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 2 ITT analysis set. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Part-2: Paliperidone Palmitate (PP) Part-2: OAP
Hide Arm/Group Description:
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants were subsequently switched to PP3M (paliperidone palmitate three-monthly injection) following a minimum of 5 injections of PP1M.
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were re-randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2).
Overall Number of Participants Analyzed 51 125
Mean (Standard Error)
Unit of Measure: units on a scale
2.5  (1.60) 2.9  (1.13)
6.Secondary Outcome
Title Part 2 (Disease Progression): Change From Baseline in Adjusted Intracortical Myelin (ICM) Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (MRI)
Hide Description The adjusted ICM fraction score is quantified as: 1. The volume of myelinated brain tissue is measured separately on co-localized IR and proton density (PD) MRI images, by outlining the boundary between gray matter and white matter on each image. 2. ICM is calculated from the difference of "IR volume minus PD volume". 3. ICM is then expressed as a fraction of the total intracranial volume (ICM divided by intracranial volume). 4. The ICM fraction is then adjusted for effects of age, gender, and race/ethnicity in the sample of treated participants and healthy controls. A decrease in the adjusted ICM fraction score may be a sign of disease progression.
Time Frame Baseline and Day 260
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 2 ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Part-2: Paliperidone Palmitate (PP) Part-2: OAP
Hide Arm/Group Description:
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants were subsequently switched to PP3M (paliperidone palmitate three-monthly injection) following a minimum of 5 injections of PP1M.
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were re-randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2).
Overall Number of Participants Analyzed 9 25
Mean (Standard Error)
Unit of Measure: ratio
-0.001  (0.002) -0.004  (0.001)
7.Secondary Outcome
Title Part 2 (Disease Progression): Change From Baseline in Working Memory Score: MCCB Domain
Hide Description MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess working memory of participants. The range of working memory score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning.
Time Frame Baseline and Day 260
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 2 ITT analysis set.
Arm/Group Title Part-2: Paliperidone Palmitate (PP) Part-2: OAP
Hide Arm/Group Description:
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants were subsequently switched to PP3M (paliperidone palmitate three-monthly injection) following a minimum of 5 injections of PP1M.
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were re-randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2).
Overall Number of Participants Analyzed 78 157
Mean (Standard Error)
Unit of Measure: T-score
-0.2  (1.08) -0.8  (0.77)
8.Secondary Outcome
Title Part 2 (Disease Progression): Change From Baseline in Verbal Learning Score: MCCB Domain
Hide Description MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess verbal learning score of participants. The range of verbal learning score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning.
Time Frame Baseline and Day 260
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 2 ITT analysis set.
Arm/Group Title Part-2: Paliperidone Palmitate (PP) Part-2: OAP
Hide Arm/Group Description:
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants were subsequently switched to PP3M (paliperidone palmitate three-monthly injection) following a minimum of 5 injections of PP1M.
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were re-randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2).
Overall Number of Participants Analyzed 78 157
Mean (Standard Error)
Unit of Measure: T-score
1.3  (1.22) 1.0  (0.85)
9.Secondary Outcome
Title Part 2 (Disease Progression): Change From Baseline in Speed of Processing Score: MCCB Domain
Hide Description MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess speed of processing score of participants. The range of speed of processing T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning.
Time Frame Baseline and Day 260
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 2 ITT analysis set.
Arm/Group Title Part-2: Paliperidone Palmitate (PP) Part-2: OAP
Hide Arm/Group Description:
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants were subsequently switched to PP3M (paliperidone palmitate three-monthly injection) following a minimum of 5 injections of PP1M.
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were re-randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2).
Overall Number of Participants Analyzed 78 157
Mean (Standard Error)
Unit of Measure: T-score
1.8  (1.21) 3.5  (0.87)
10.Secondary Outcome
Title Part 2 (Disease Progression): Change From Baseline in Attention/Vigilance Score: MCCB Domain
Hide Description MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess attention/vigilance score of participants. The range of attention/vigilance score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning.
Time Frame Baseline and Day 260
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 2 ITT analysis set.
Arm/Group Title Part-2: Paliperidone Palmitate (PP) Part-2: OAP
Hide Arm/Group Description:
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants were subsequently switched to PP3M (paliperidone palmitate three-monthly injection) following a minimum of 5 injections of PP1M.
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were re-randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2).
Overall Number of Participants Analyzed 78 157
Mean (Standard Error)
Unit of Measure: T-score
3.2  (1.18) 0.7  (0.85)
11.Secondary Outcome
Title Part 2 (Disease Progression): Change From Baseline in Visual Learning Score: MCCB Domain
Hide Description MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess visual learning score of participants. The range of visual learning score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning.
Time Frame Baseline and Day 260
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on part 2 ITT analysis set.
Arm/Group Title Part-2: Paliperidone Palmitate (PP) Part-2: OAP
Hide Arm/Group Description:
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants were subsequently switched to PP3M (paliperidone palmitate three-monthly injection) following a minimum of 5 injections of PP1M.
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were re-randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2).
Overall Number of Participants Analyzed 78 157
Mean (Standard Error)
Unit of Measure: T-score
1.3  (1.29) 1.4  (0.93)
12.Secondary Outcome
Title Part 2 (Disease Progression): Change From Baseline in Reasoning and Problem Solving: MCCB Domain
Hide Description MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess reasoning and problem solving of participants. The range of reasoning and problem solving T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning.
Time Frame Baseline and Day 260
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 2 ITT analysis set.
Arm/Group Title Part-2: Paliperidone Palmitate (PP) Part-2: OAP
Hide Arm/Group Description:
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants were subsequently switched to PP3M (paliperidone palmitate three-monthly injection) following a minimum of 5 injections of PP1M.
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were re-randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2).
Overall Number of Participants Analyzed 78 157
Mean (Standard Error)
Unit of Measure: T-score
0.2  (1.16) 2.8  (0.83)
13.Secondary Outcome
Title Part 2 (Disease Progression): Change From Baseline in Social Cognition Score: MCCB Domain
Hide Description MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess social cognition score of participants. The range of social cognition score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning.
Time Frame Baseline and Day 260
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Hide Analysis Population Description
Analysis was performed on Part 2 ITT analysis set.
Arm/Group Title Part-2: Paliperidone Palmitate (PP) Part-2: OAP
Hide Arm/Group Description:
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants were subsequently switched to PP3M (paliperidone palmitate three-monthly injection) following a minimum of 5 injections of PP1M.
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were re-randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2).
Overall Number of Participants Analyzed 78 157
Mean (Standard Error)
Unit of Measure: T-score
0.3  (1.25) 1.6  (0.89)
14.Secondary Outcome
Title Part 2 (Disease Progression): Change From Baseline in Clinical Global Impression Severity (CGI-S) Score
Hide Description The Clinical Global Impression Severity (CGI-S) rating scale is used to rate the severity of a participant's overall clinical condition on a 7 point scale. The score ranges from 1 to 7, where 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.
Time Frame Baseline, up to 9 Months of Part 2
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Hide Analysis Population Description
Analysis was performed on Part 2 ITT analysis set. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Part-2: Paliperidone Palmitate (PP) Part-2: OAP
Hide Arm/Group Description:
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants were subsequently switched to PP3M (paliperidone palmitate three-monthly injection) following a minimum of 5 injections of PP1M.
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were re-randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2).
Overall Number of Participants Analyzed 52 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.2  (1.06) -0.3  (0.94)
15.Secondary Outcome
Title Part 2 (Disease Progression): Number of Participants With Change From Baseline in Severity of Psychotic Symptoms, as Measured by Clinician-Rated Dimensions of Psychosis Symptom Severity Scale (CRDPSS)
Hide Description The CRDPSS is an 8-item measure that assesses the severity of mental health symptoms that are important across psychotic disorders, including delusions, hallucinations, disorganized speech, abnormal psychomotor behavior, negative symptoms. Each item on the measure is rated on a 5-point scale (0=none; 1=equivocal; 2=present, but mild; 3=present and moderate; and 4=present and severe). Total Score is taken as summation. A higher score indicates a more severe condition. Worsened or improved is defined as increase or decrease compared to baseline.
Time Frame Baseline, up to 9 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 2 ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Part-2: Paliperidone Palmitate (PP) Part-2: OAP
Hide Arm/Group Description:
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants were subsequently switched to PP3M (paliperidone palmitate three-monthly injection) following a minimum of 5 injections of PP1M.
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were re-randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2).
Overall Number of Participants Analyzed 50 125
Measure Type: Count of Participants
Unit of Measure: Participants
Hallucinations Worsened
7
  14.0%
19
  15.2%
Unchanged
29
  58.0%
73
  58.4%
Improved
14
  28.0%
33
  26.4%
Delusions Worsened
10
  20.0%
20
  16.0%
Unchanged
23
  46.0%
70
  56.0%
Improved
17
  34.0%
35
  28.0%
Disorganized Speech Worsened
2
   4.0%
13
  10.4%
Unchanged
36
  72.0%
85
  68.0%
Improved
12
  24.0%
27
  21.6%
Abnormal Psychomotor Behavior Worsened
9
  18.0%
14
  11.2%
Unchanged
37
  74.0%
86
  68.8%
Improved
4
   8.0%
25
  20.0%
Negative Symptoms Worsened
17
  34.0%
25
  20.0%
Unchanged
16
  32.0%
61
  48.8%
Improved
17
  34.0%
39
  31.2%
Impaired Cognition Worsened
13
  26.0%
29
  23.2%
Unchanged
22
  44.0%
52
  41.6%
Improved
15
  30.0%
44
  35.2%
Mania Worsened
1
   2.0%
7
   5.6%
Unchanged
47
  94.0%
107
  85.6%
Improved
2
   4.0%
11
   8.8%
Depression Worsened
7
  14.0%
28
  22.4%
Unchanged
33
  66.0%
74
  59.2%
Improved
10
  20.0%
23
  18.4%
16.Secondary Outcome
Title Part 2 (Disease Progression): Change From Baseline in Medication Satisfaction Questionnaire (MSQ) Total Score
Hide Description The Medication Satisfaction Questionnaire (MSQ) is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied). Total score ranges from 1 to 7. Higher score indicate improvement.
Time Frame Baseline and endpoint Part 2 (up to 9 Months)
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Hide Analysis Population Description
Analysis was performed on Part 2 ITT analysis set. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Part-2: Paliperidone Palmitate (PP) Part-2: OAP
Hide Arm/Group Description:
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants were subsequently switched to PP3M (paliperidone palmitate three-monthly injection) following a minimum of 5 injections of PP1M.
Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were re-randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2).
Overall Number of Participants Analyzed 73 156
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.2  (1.44) 0.1  (1.16)
17.Secondary Outcome
Title Part 3 (EDP): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score
Hide Description The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Each domain was assessed on a 6-point scale, from 1 (absent) to 6 (very severe) (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe). PSP total score was calculated as sum of all the domain scores and ranges from 1 to 100. 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. Higher score indicate better performance.
Time Frame Baseline and 18 Months
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Hide Analysis Population Description
Analysis was performed on part 3 ITT analysis set. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Part 3-PP to PP Part 3-OAP to OAP
Hide Arm/Group Description:
Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
Overall Number of Participants Analyzed 41 47
Mean (Standard Error)
Unit of Measure: units on a scale
7.5  (1.94) 7.0  (1.82)
18.Secondary Outcome
Title Part 3 (EDP): Change From Baseline in Adjusted Intracortical Myelin Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (MRI)
Hide Description The adjusted ICM fraction score is quantified as: 1. The volume of myelinated brain tissue is measured separately on co-localized IR and proton density (PD) MRI images, by outlining the boundary between gray matter and white matter on each image. 2. ICM is calculated from the difference of "IR volume minus PD volume". 3. ICM is then expressed as a fraction of the total intracranial volume (ICM divided by intracranial volume). 4. The ICM fraction is then adjusted for effects of age, gender, and race/ethnicity in the sample of treated participants and healthy controls. A decrease in the adjusted ICM fraction score may be a sign of disease progression.
Time Frame Baseline and 18 Months
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Hide Analysis Population Description
Analysis was performed on Part 3 ITT analysis set.
Arm/Group Title Part 3-PP to PP Part 3-OAP to OAP
Hide Arm/Group Description:
Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
Overall Number of Participants Analyzed 49 63
Mean (Standard Error)
Unit of Measure: ratio
-0.001  (0.001) -0.003  (0.001)
19.Secondary Outcome
Title Part 3 (EDP): Time to First Treatment Failure
Hide Description Treatment failure is defined as the time from participant's randomization to first treatment failure, which was a composite endpoint consisting of any of the following: 1) Psychiatric hospitalization due to worsening symptoms; 2) Any deliberate self-injury, suicidal ideation or behavior, homicidal ideation or violent behavior that is clinically significant and needs immediate intervention as determined by the study physician; 3) New arrest/incarceration; 4) Discontinuation of antipsychotic treatment due to inadequate efficacy as determined by the study physician; 5) Discontinuation of antipsychotic treatment due to safety or tolerability as determined by the study physician; 6) Treatment supplementation with another antipsychotic due to inadequate efficacy as determined by the study physician; 7) Increase in the level of psychiatric services in order to prevent imminent psychiatric hospitalization as determined by the study physician.
Time Frame From Day 1 Up to 18 Months
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Hide Analysis Population Description
Analysis was performed on Part 3 ITT analysis set.
Arm/Group Title Part 3-PP to PP Part 3-OAP to OAP
Hide Arm/Group Description:
Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
Overall Number of Participants Analyzed 49 63
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(376.0 to NA)
[1]
Here, NA signifies that median and upper/lower limit of CI was not estimable due to less number of events.
20.Secondary Outcome
Title Part 3 (EDP): Change From Baseline in Working Memory Score: MCCB Domain
Hide Description MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess working memory of participants. The range of working memory score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning.
Time Frame Baseline and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 3 ITT analysis set.
Arm/Group Title Part 3-PP to PP Part 3-OAP to OAP
Hide Arm/Group Description:
Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
Overall Number of Participants Analyzed 49 63
Mean (Standard Error)
Unit of Measure: T-score
-1.7  (1.24) 0.7  (1.16)
21.Secondary Outcome
Title Part 3 (EDP): Change From Baseline in Verbal Learning Score: MCCB Domain
Hide Description MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess verbal learning score of participants. The range of verbal learning score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning.
Time Frame Baseline and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 3 ITT analysis set.
Arm/Group Title Part 3-PP to PP Part 3-OAP to OAP
Hide Arm/Group Description:
Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
Overall Number of Participants Analyzed 49 63
Mean (Standard Error)
Unit of Measure: T-score
0.3  (1.24) 0.8  (1.15)
22.Secondary Outcome
Title Part 3 (EDP): Change From Baseline in Speed of Processing Score: MCCB Domain
Hide Description MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess speed of processing score of participants. The range of speed of processing score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning.
Time Frame Baseline and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 3 ITT analysis set.
Arm/Group Title Part 3-PP to PP Part 3-OAP to OAP
Hide Arm/Group Description:
Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
Overall Number of Participants Analyzed 49 63
Mean (Standard Error)
Unit of Measure: T-score
2.5  (1.32) 4.9  (1.24)
23.Secondary Outcome
Title Part 3 (EDP): Change From Baseline in Attention/Vigilance Score: MCCB Domain
Hide Description MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess attention/vigilance score of participants. The range of attention/vigilance score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning.
Time Frame Baseline and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 3 ITT analysis set.
Arm/Group Title Part 3-PP to PP Part 3-OAP to OAP
Hide Arm/Group Description:
Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
Overall Number of Participants Analyzed 49 63
Mean (Standard Error)
Unit of Measure: T-score
2.4  (1.46) 0.7  (1.35)
24.Secondary Outcome
Title Part 3 (EDP): Change From Baseline in Visual Learning Score: MCCB Domain
Hide Description MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess visual learning score of participants. The range of visual learning score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning.
Time Frame Baseline and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 3 ITT analysis set.
Arm/Group Title Part 3-PP to PP Part 3-OAP to OAP
Hide Arm/Group Description:
Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
Overall Number of Participants Analyzed 49 63
Mean (Standard Error)
Unit of Measure: T-score
0.2  (1.42) -0.2  (1.35)
25.Secondary Outcome
Title Part 3 (EDP): Change From Baseline in Reasoning and Problem Solving: MCCB Domain
Hide Description MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess reasoning and problem solving score of participants. The range of reasoning and problem solving T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning.
Time Frame Baseline and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 3 ITT analysis set.
Arm/Group Title Part 3-PP to PP Part 3-OAP to OAP
Hide Arm/Group Description:
Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
Overall Number of Participants Analyzed 49 63
Mean (Standard Error)
Unit of Measure: T-score
3.4  (1.46) 4.7  (1.34)
26.Secondary Outcome
Title Part 3 (EDP): Change From Baseline in Social Cognition Score: MCCB Domain
Hide Description MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess social cognition score of participants. The range of social cognition score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning.
Time Frame Baseline and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 3 ITT analysis set.
Arm/Group Title Part 3-PP to PP Part 3-OAP to OAP
Hide Arm/Group Description:
Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
Overall Number of Participants Analyzed 49 63
Mean (Standard Error)
Unit of Measure: T-score
-0.2  (1.36) 1.4  (1.26)
27.Secondary Outcome
Title Part 3 (EDP): Change From Baseline in Clinical Global Impression Severity (CGI-S) Score
Hide Description The Clinical Global Impression Severity (CGI-S) rating scale is used to rate the severity of a participant's overall clinical condition on a 7 point scale. The total score ranges from 1 to 7, where 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.
Time Frame Baseline, up to 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 3 ITT analysis set.
Arm/Group Title Part 3-PP to PP Part 3-OAP to OAP
Hide Arm/Group Description:
Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
Overall Number of Participants Analyzed 49 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.7  (0.14) -0.7  (0.14)
28.Secondary Outcome
Title Part 3 (EDP): Number of Participants With Change From Baseline in Severity of Psychotic Symptoms, as Measured by CRDPSS
Hide Description The CRDPSS is an 8-item measure that assesses the severity of mental health symptoms that are important across psychotic disorders, including delusions, hallucinations, disorganized speech, abnormal psychomotor behavior, negative symptoms. Each item on the measure is rated on a 5-point scale (0=none; 1=equivocal; 2=present, but mild; 3=present and moderate; and 4=present and severe). Total Score is taken as summation. A higher score indicates a more severe condition. Worsened or improved is defined as increase or decrease compared to baseline.
Time Frame Baseline, up to 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Part 3 ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group Title Part 3-PP to PP Part 3-OAP to OAP
Hide Arm/Group Description:
Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
Overall Number of Participants Analyzed 41 47
Measure Type: Count of Participants
Unit of Measure: Participants
Hallucinations Worsened
3
   7.3%
8
  17.0%
Unchanged
27
  65.9%
29
  61.7%
Improved
11
  26.8%
10
  21.3%
Delusions Worsened
6
  14.6%
10
  21.3%
Unchanged
21
  51.2%
20
  42.6%
Improved
14
  34.1%
17
  36.2%
Disorganized Speech Worsened
2
   4.9%
3
   6.4%
Unchanged
27
  65.9%
36
  76.6%
Improved
12
  29.3%
8
  17.0%
Abnormal Psychomotor Behavior Worsened
4
   9.8%
2
   4.3%
Unchanged
32
  78.0%
37
  78.7%
Improved
5
  12.2%
8
  17.0%
Negative Symptoms Worsened
11
  26.8%
4
   8.5%
Unchanged
11
  26.8%
22
  46.8%
Improved
19
  46.3%
21
  44.7%
Impaired Cognition Worsened
10
  24.4%
9
  19.1%
Unchanged
14
  34.1%
23
  48.9%
Improved
17
  41.5%
15
  31.9%
Mania Worsened
0
   0.0%
3
   6.4%
Unchanged
40
  97.6%
39
  83.0%
Improved
1
   2.4%
5
  10.6%
Depression Worsened
7
  17.1%
6
  12.8%
Unchanged
26
  63.4%
29
  61.7%
Improved
8
  19.5%
12
  25.5%
29.Secondary Outcome
Title Part 3 (EDP): Change From Baseline in Medication Satisfaction Questionnaire (MSQ) Score
Hide Description The Medication Satisfaction Questionnaire (MSQ) is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied). Total score ranges from 1 to 7. Higher score indicate improvement.
Time Frame Baseline, up to 18 Months
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Hide Analysis Population Description
Analysis was performed on part 3 ITT analysis set.
Arm/Group Title Part 3-PP to PP Part 3-OAP to OAP
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Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
Overall Number of Participants Analyzed 49 63
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.3  (0.18) 0.4  (0.18)
30.Secondary Outcome
Title Part 3 (Disease Modification): Personal and Social Performance (PSP) Total Observed Score
Hide Description The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe) in each of the 4 domains. Based on 4 domains there will be 1 transformed 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.
Time Frame Month 9 of Part 3
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Hide Analysis Population Description
Analysis was performed on Part 3 ITT analysis set.
Arm/Group Title Part 3-PP to PP Part 3- OAP to PP (or Delayed-Start PP) Part 3-OAP to OAP
Hide Arm/Group Description:
Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive PP treatment for additional 9 months (up to Day 260). PP treatment includes PP1M and PP3M. Participants subsequently switched to PP3M following a minimum of 5 injections of PP1M.
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
Overall Number of Participants Analyzed 49 57 63
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
67.6  (1.81) 66.1  (1.70) 66.6  (1.70)
31.Secondary Outcome
Title Part 3 (Disease Modification): Change From Baseline in Adjusted Intracortical Myelin Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (SE MRI)
Hide Description The adjusted ICM fraction score is quantified as: 1. The volume of myelinated brain tissue is measured separately on co-localized IR and proton density (PD) MRI images, by outlining the boundary between gray matter and white matter on each image. 2. ICM is calculated from the difference of "IR volume minus PD volume". 3. ICM is then expressed as a fraction of the total intracranial volume (ICM divided by intracranial volume). 4. The ICM fraction is then adjusted for effects of age, gender, and race/ethnicity in the sample of treated participants and healthy controls. A decrease in the adjusted ICM fraction score may be a sign of disease progression.
Time Frame Baseline and Month 9 of Part 3
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Hide Analysis Population Description
Analysis was performed on Part 3 ITT analysis set. Here 'N' (number of participants analyzed) signifies number of participants analyzed for this outcome measure.
Arm/Group Title Part 3-PP to PP Part 3- OAP to PP (or Delayed-Start PP) Part 3-OAP to OAP
Hide Arm/Group Description:
Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3).
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive PP treatment for additional 9 months (up to Day 260). PP treatment includes PP1M and PP3M. Participants subsequently switched to PP3M following a minimum of 5 injections of PP1M.
Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
Overall Number of Participants Analyzed 10 8 9
Least Squares Mean (Standard Error)
Unit of Measure: ratio
-0.7  (1.02) -0.2  (0.95) 0.5  (0.96)
Time Frame Up to 20 Months
Adverse Event Reporting Description Safety analysis was based on Part 1, 2 and 3 Intent-to-Treat (ITT) analysis set. Part 1, 2 and 3 ITT analysis set included all randomized subjects who received at least one dose of study medication (or any portion of the dose) in Part 1, 2 and 3 regardless of their compliance with the protocol.
 
Arm/Group Title Part 1-Run-in: Oral Antipsychotics (OAP) Part 2-Paliperidone Palmitate (PP) Part 2-OAP Part 3-PP to PP (Extended Disease Progression [EDP] and Disease Modification) Part 3- OAP to PP (or Delayed-Start PP) (Disease Modification) Part 3-OAP to OAP (EDP and Disease Modification)
Hide Arm/Group Description All participants received paliperidone extended Release (ER) 1.5 to 12 milligrams (mg) or risperidone 1 to 6 mg once daily orally for 2 months. Participants who tolerated paliperidone ER/risperidone but found it inadequately efficacious after treatment for an adequate duration at an adequate dosage (per clinical judgment), may be switched to another protocol-specified OAP at the discretion of the investigator. Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who were randomized to the PP treatment group received a minimum of 5 doses of PP1M with fixed initial doses of 234 mg on Day 1 and 156 mg on Day 8, followed by 3 injections of flexible doses. On Day 120, participants received PP3M for the remaining 9 months. Participants who completed Part 1 with acceptable run-in dosages were eligible to enter Part 2. Participants who completed Part 1 were randomized to OAP treatment group and continued their OAP treatment from Part 1 for another 9 months (up to Day 260 of Part 2). Participants who completed Part 2 and who were eligible based on matched criteria identified in Part 1 continued on the PP Treatment Group in Part 3. Participants continued to receive Paliperidone Palmitate for another 9 months (up to Day 260 Part 3). Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive PP treatment for additional 9 months (up to Day 260). PP treatment includes PP1M or PP3M. Participants subsequently switched to PP3M following a minimum of 5 injections of PP1M. Participants who completed Part 2 (with OAP treatment) and who were eligible based on matched criteria identified in Part 1 were re-randomized to receive OAP treatment for another 9 months (up to Day 260 of Part 3).
All-Cause Mortality
Part 1-Run-in: Oral Antipsychotics (OAP) Part 2-Paliperidone Palmitate (PP) Part 2-OAP Part 3-PP to PP (Extended Disease Progression [EDP] and Disease Modification) Part 3- OAP to PP (or Delayed-Start PP) (Disease Modification) Part 3-OAP to OAP (EDP and Disease Modification)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/273 (0.00%)   1/78 (1.28%)   0/157 (0.00%)   0/49 (0.00%)   0/57 (0.00%)   0/63 (0.00%) 
Hide Serious Adverse Events
Part 1-Run-in: Oral Antipsychotics (OAP) Part 2-Paliperidone Palmitate (PP) Part 2-OAP Part 3-PP to PP (Extended Disease Progression [EDP] and Disease Modification) Part 3- OAP to PP (or Delayed-Start PP) (Disease Modification) Part 3-OAP to OAP (EDP and Disease Modification)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/273 (3.66%)   10/78 (12.82%)   19/157 (12.10%)   1/49 (2.04%)   3/57 (5.26%)   8/63 (12.70%) 
Cardiac disorders             
Tachycardia * 1  1/273 (0.37%)  0/78 (0.00%)  0/157 (0.00%)  0/49 (0.00%)  0/57 (0.00%)  0/63 (0.00%) 
General disorders             
Asthenia * 1  0/273 (0.00%)  1/78 (1.28%)  0/157 (0.00%)  0/49 (0.00%)  0/57 (0.00%)  0/63 (0.00%) 
Infections and infestations             
Appendicitis * 1  1/273 (0.37%)  0/78 (0.00%)  0/157 (0.00%)  0/49 (0.00%)  0/57 (0.00%)  0/63 (0.00%) 
Injury, poisoning and procedural complications             
Exposure Via Inhalation * 1  0/273 (0.00%)  1/78 (1.28%)  0/157 (0.00%)  0/49 (0.00%)  0/57 (0.00%)  0/63 (0.00%) 
Overdose * 1  1/273 (0.37%)  0/78 (0.00%)  1/157 (0.64%)  0/49 (0.00%)  0/57 (0.00%)  0/63 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Ganglioglioma * 1  0/273 (0.00%)  0/78 (0.00%)  0/157 (0.00%)  1/49 (2.04%)  0/57 (0.00%)  0/63 (0.00%) 
Psychiatric disorders             
Agitation * 1  0/273 (0.00%)  1/78 (1.28%)  0/157 (0.00%)  0/49 (0.00%)  0/57 (0.00%)  0/63 (0.00%) 
Catatonia * 1  0/273 (0.00%)  0/78 (0.00%)  0/157 (0.00%)  0/49 (0.00%)  0/57 (0.00%)  1/63 (1.59%) 
Completed Suicide * 1  0/273 (0.00%)  0/78 (0.00%)  0/157 (0.00%)  0/49 (0.00%)  1/57 (1.75%)  0/63 (0.00%) 
Depressed Mood * 1  0/273 (0.00%)  1/78 (1.28%)  0/157 (0.00%)  0/49 (0.00%)  0/57 (0.00%)  0/63 (0.00%) 
Homicidal Ideation * 1  0/273 (0.00%)  1/78 (1.28%)  0/157 (0.00%)  0/49 (0.00%)  0/57 (0.00%)  0/63 (0.00%) 
Mania * 1  1/273 (0.37%)  0/78 (0.00%)  0/157 (0.00%)  0/49 (0.00%)  0/57 (0.00%)  0/63 (0.00%) 
Mental Status Changes * 1  0/273 (0.00%)  0/78 (0.00%)  1/157 (0.64%)  0/49 (0.00%)  0/57 (0.00%)  0/63 (0.00%) 
Psychotic Disorder * 1  1/273 (0.37%)  4/78 (5.13%)  5/157 (3.18%)  0/49 (0.00%)  0/57 (0.00%)  4/63 (6.35%) 
Psychotic Symptom * 1  1/273 (0.37%)  0/78 (0.00%)  3/157 (1.91%)  0/49 (0.00%)  0/57 (0.00%)  2/63 (3.17%) 
Schizophrenia * 1  3/273 (1.10%)  3/78 (3.85%)  6/157 (3.82%)  0/49 (0.00%)  0/57 (0.00%)  1/63 (1.59%) 
Suicidal Ideation * 1  0/273 (0.00%)  3/78 (3.85%)  4/157 (2.55%)  0/49 (0.00%)  2/57 (3.51%)  0/63 (0.00%) 
Suicide Attempt * 1  1/273 (0.37%)  1/78 (1.28%)  0/157 (0.00%)  0/49 (0.00%)  0/57 (0.00%)  0/63 (0.00%) 
1
Term from vocabulary, MedDRA Version 21.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1-Run-in: Oral Antipsychotics (OAP) Part 2-Paliperidone Palmitate (PP) Part 2-OAP Part 3-PP to PP (Extended Disease Progression [EDP] and Disease Modification) Part 3- OAP to PP (or Delayed-Start PP) (Disease Modification) Part 3-OAP to OAP (EDP and Disease Modification)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   116/273 (42.49%)   50/78 (64.10%)   89/157 (56.69%)   18/49 (36.73%)   34/57 (59.65%)   27/63 (42.86%) 
Gastrointestinal disorders             
Nausea * 1  5/273 (1.83%)  4/78 (5.13%)  11/157 (7.01%)  2/49 (4.08%)  2/57 (3.51%)  5/63 (7.94%) 
General disorders             
Fatigue * 1  10/273 (3.66%)  4/78 (5.13%)  1/157 (0.64%)  0/49 (0.00%)  5/57 (8.77%)  1/63 (1.59%) 
Injection Site Pain * 1  4/273 (1.47%)  6/78 (7.69%)  2/157 (1.27%)  0/49 (0.00%)  0/57 (0.00%)  0/63 (0.00%) 
Infections and infestations             
Nasopharyngitis * 1  1/273 (0.37%)  5/78 (6.41%)  4/157 (2.55%)  3/49 (6.12%)  0/57 (0.00%)  4/63 (6.35%) 
Upper Respiratory Tract Infection * 1  6/273 (2.20%)  1/78 (1.28%)  7/157 (4.46%)  1/49 (2.04%)  3/57 (5.26%)  2/63 (3.17%) 
Investigations             
Blood Prolactin Increased * 1  8/273 (2.93%)  3/78 (3.85%)  9/157 (5.73%)  1/49 (2.04%)  0/57 (0.00%)  1/63 (1.59%) 
Weight Increased * 1  44/273 (16.12%)  22/78 (28.21%)  50/157 (31.85%)  7/49 (14.29%)  9/57 (15.79%)  5/63 (7.94%) 
Musculoskeletal and connective tissue disorders             
Musculoskeletal Stiffness * 1  2/273 (0.73%)  4/78 (5.13%)  3/157 (1.91%)  0/49 (0.00%)  1/57 (1.75%)  2/63 (3.17%) 
Nervous system disorders             
Akathisia * 1  10/273 (3.66%)  7/78 (8.97%)  8/157 (5.10%)  0/49 (0.00%)  4/57 (7.02%)  0/63 (0.00%) 
Headache * 1  11/273 (4.03%)  7/78 (8.97%)  12/157 (7.64%)  1/49 (2.04%)  2/57 (3.51%)  4/63 (6.35%) 
Sedation * 1  16/273 (5.86%)  3/78 (3.85%)  3/157 (1.91%)  0/49 (0.00%)  2/57 (3.51%)  0/63 (0.00%) 
Somnolence * 1  19/273 (6.96%)  7/78 (8.97%)  4/157 (2.55%)  1/49 (2.04%)  3/57 (5.26%)  1/63 (1.59%) 
Tremor * 1  6/273 (2.20%)  1/78 (1.28%)  7/157 (4.46%)  2/49 (4.08%)  5/57 (8.77%)  2/63 (3.17%) 
Psychiatric disorders             
Anxiety * 1  5/273 (1.83%)  5/78 (6.41%)  4/157 (2.55%)  0/49 (0.00%)  6/57 (10.53%)  3/63 (4.76%) 
Insomnia * 1  9/273 (3.30%)  4/78 (5.13%)  9/157 (5.73%)  5/49 (10.20%)  6/57 (10.53%)  4/63 (6.35%) 
Paranoia * 1  0/273 (0.00%)  0/78 (0.00%)  0/157 (0.00%)  3/49 (6.12%)  0/57 (0.00%)  1/63 (1.59%) 
Schizophrenia * 1  3/273 (1.10%)  1/78 (1.28%)  4/157 (2.55%)  1/49 (2.04%)  3/57 (5.26%)  1/63 (1.59%) 
1
Term from vocabulary, MedDRA Version 21.1
*
Indicates events were collected by non-systematic assessment
The treatment failure (TF) definition for this study was very broad. For example, the TF reason, supplementation with another antipsychotic, was biased against PP as supplementing with oral paliperidone or risperidone was considered a TF which is usual clinical practice. Supplementation was the most common first TF criteria for PP. A designated individual of the subject was a requirement for study inclusion which may have also contributed to increased OAP adherence in the beginning of the study.
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 the 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 in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
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Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT02431702    
Other Study ID Numbers: CR106193
R092670SCH3013 ( Other Identifier: Janssen Scientific Affairs, LLC )
First Submitted: April 28, 2015
First Posted: May 1, 2015
Results First Submitted: November 11, 2020
Results First Posted: January 19, 2021
Last Update Posted: January 19, 2021