Trial · NCT02431702
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
NCT02431702, Phase 3, Completed, Janssen Scientific Affairs, LLC; results first posted 2021-01-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT02431702. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02431702
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT02431702
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 337 participants, actual
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Conditions
- Schizophrenia, Psychotic Disorders
- Interventions
- Aripiprazole, Haloperidol, Olanzapine, Oral Paliperidone ER, Perphenazine, Quetiapine, Oral Risperidone, Paliperidone Palmitate Injection (PP1M), Paliperidone Palmitate Injection (PP3M)
- First posted
- 2015-05-01
- Last updated
- 2025-04-29
- Results first posted
- 2021-01-19
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part-2 (Disease Progression): Time to First Treatment Failure | From Day 1 up to 9 Months | 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. |
| Primary | Part 3 (Extended Disease Progression [EDP]): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score | Baseline and 18 Months | 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. |
| Primary | Part 3 (Disease Modification): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score | Baseline and Day 260 | 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. |
| Secondary | Part 2 (Disease Progression): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score | Baseline and Month 9 | 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. |
| Secondary | Part 2 (Disease Progression): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score | Baseline and Month 9 | 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. |
| Secondary | 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) | Baseline and Day 260 | 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. |
| Secondary | Part 2 (Disease Progression): Change From Baseline in Working Memory Score: MCCB Domain | Baseline and Day 260 | 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. |
| Secondary | Part 2 (Disease Progression): Change From Baseline in Verbal Learning Score: MCCB Domain | Baseline and Day 260 | 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. |
| Secondary | Part 2 (Disease Progression): Change From Baseline in Speed of Processing Score: MCCB Domain | Baseline and Day 260 | 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. |
| Secondary | Part 2 (Disease Progression): Change From Baseline in Attention/Vigilance Score: MCCB Domain | Baseline and Day 260 | 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. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part-2 (Disease Progression): Time to First Treatment Failure | From Day 1 up to 9 Months | 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. | days | MEDIAN |
| PRIMARY | Part 3 (Extended Disease Progression [EDP]): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score | Baseline and 18 Months | 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. | T-score | MEAN |
| PRIMARY | Part 3 (Disease Modification): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score | Baseline and Day 260 | 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. | T-score | MEAN |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score | Baseline and Month 9 | 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. | T-score | LEAST_SQUARES_MEAN |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score | Baseline and Month 9 | 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. | units on a scale | MEAN |
| SECONDARY | 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) | Baseline and Day 260 | Analysis was performed on Part 2 ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure. | ratio | MEAN |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Working Memory Score: MCCB Domain | Baseline and Day 260 | Analysis was performed on Part 2 ITT analysis set. | T-score | MEAN |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Verbal Learning Score: MCCB Domain | Baseline and Day 260 | Analysis was performed on Part 2 ITT analysis set. | T-score | MEAN |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Speed of Processing Score: MCCB Domain | Baseline and Day 260 | Analysis was performed on Part 2 ITT analysis set. | T-score | MEAN |
| SECONDARY | Part 2 (Disease Progression): Change From Baseline in Attention/Vigilance Score: MCCB Domain | Baseline and Day 260 | Analysis was performed on Part 2 ITT analysis set. | T-score | MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group157
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part-2 (Disease Progression): Time to First Treatment Failure | Part-2: Paliperidone Palmitate (PP) | NA | 95% Confidence Interval 263.0 to NA | days | |
| Part-2 (Disease Progression): Time to First Treatment Failure | Part-2: OAP | NA | 95% Confidence Interval NA to NA | days | |
| Part 3 (Extended Disease Progression [EDP]): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score | Part 3-PP to PP | 1.6 | Standard Error 1.19 | T-score | |
| Part 3 (Extended Disease Progression [EDP]): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score | Part 3-OAP to OAP | 3.2 | Standard Error 1.11 | T-score | |
| Part 3 (Disease Modification): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score | Part 3- PP to PP | -0.7 | Standard Error 1.02 | T-score | |
| Part 3 (Disease Modification): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score | Part 3- OAP to PP (or Delayed-Start PP) | -0.2 | Standard Error 0.95 | T-score | |
| Part 3 (Disease Modification): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score | Part 3-OAP to OAP | 0.5 | Standard Error 0.96 | T-score | |
| Part 2 (Disease Progression): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score | Part-2: Paliperidone Palmitate (PP) | 2.0 | Standard Error 1.01 | T-score | |
| Part 2 (Disease Progression): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score | Part-2: OAP | 2.8 | Standard Error 0.73 | T-score | |
| Part 2 (Disease Progression): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score | Part-2: Paliperidone Palmitate (PP) | 2.5 | Standard Error 1.60 | units on a scale |
1 to 10 of 157Source ClinicalTrials.gov
See all 157 results by groupParticipant flow63
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1: 2-Month Oral Run-in Phase | STARTED | Part 1-Run-in: Oral Antipsychotics (OAP) | 273 | |
| Part 1: 2-Month Oral Run-in Phase | STARTED | Part 2-Paliperidone Palmitate (PP) | 0 | |
| Part 1: 2-Month Oral Run-in Phase | STARTED | Part 2-OAP | 0 | |
| Part 1: 2-Month Oral Run-in Phase | STARTED | Part 3-PP to PP (Extended Disease Progression [EDP] and Disease Modification) | 0 | |
| Part 1: 2-Month Oral Run-in Phase | STARTED | Part 3- OAP to PP (or Delayed-Start PP) (Disease Modification) | 0 | |
| Part 1: 2-Month Oral Run-in Phase | STARTED | Part 3-OAP to OAP (EDP and Disease Modification) | 0 | |
| Part 1: 2-Month Oral Run-in Phase | STARTED | Healthy Controls | 64 | |
| Part 1: 2-Month Oral Run-in Phase | COMPLETED | Part 1-Run-in: Oral Antipsychotics (OAP) | 239 | |
| Part 1: 2-Month Oral Run-in Phase | COMPLETED | Part 2-Paliperidone Palmitate (PP) | 0 | |
| Part 1: 2-Month Oral Run-in Phase | COMPLETED | Part 2-OAP | 0 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 participant flowAdverse events210
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Part 1-Run-in: Oral Antipsychotics (OAP) | 5 | 273 | |
| other | Nausea | Gastrointestinal disorders | Part 2-Paliperidone Palmitate (PP) | 4 | 78 | |
| other | Nausea | Gastrointestinal disorders | Part 2-OAP | 11 | 157 | |
| other | Nausea | Gastrointestinal disorders | Part 3-PP to PP (Extended Disease Progression [EDP] and Disease Modification) | 2 | 49 | |
| other | Nausea | Gastrointestinal disorders | Part 3- OAP to PP (or Delayed-Start PP) (Disease Modification) | 2 | 57 | |
| other | Nausea | Gastrointestinal disorders | Part 3-OAP to OAP (EDP and Disease Modification) | 5 | 63 | |
| other | Fatigue | General disorders | Part 1-Run-in: Oral Antipsychotics (OAP) | 10 | 273 | |
| other | Fatigue | General disorders | Part 2-Paliperidone Palmitate (PP) | 4 | 78 | |
| other | Fatigue | General disorders | Part 2-OAP | 1 | 157 | |
| other | Fatigue | General disorders | Part 3-PP to PP (Extended Disease Progression [EDP] and Disease Modification) | 0 | 49 |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1-Run-in: Oral Antipsychotics (OAP) | 0 | 273 |
| Total, all-cause mortality | Part 2-Paliperidone Palmitate (PP) | 1 | 78 |
| Total, all-cause mortality | Part 2-OAP | 0 | 157 |
| Total, all-cause mortality | Part 3-PP to PP (Extended Disease Progression [EDP] and Disease Modification) | 0 | 49 |
| Total, all-cause mortality | Part 3- OAP to PP (or Delayed-Start PP) (Disease Modification) | 0 | 57 |
| Total, all-cause mortality | Part 3-OAP to OAP (EDP and Disease Modification) | 0 | 63 |
| Total, other adverse events | Part 1-Run-in: Oral Antipsychotics (OAP) | 116 | 273 |
| Total, other adverse events | Part 2-Paliperidone Palmitate (PP) | 50 | 78 |
| Total, other adverse events | Part 2-OAP | 89 | 157 |
| Total, other adverse events | Part 3-PP to PP (Extended Disease Progression [EDP] and Disease Modification) | 18 | 49 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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