Trial · NCT01515423
Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia
NCT01515423, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2016-05-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia. Trials, record NCT01515423. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01515423
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia
- NCT number
- NCT01515423
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,429 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Schizophrenia
- Interventions
- PP3M 175 mg eq., PP3M 263 mg eq., PP3M 350 mg eq., PP3M 525 mg eq., Placebo (20% Intralipid), PP1M 50 mg eq., PP1M 75 mg eq., PP1M 100 mg eq., PP1M 150 mg eq.
- First posted
- 2012-01-24
- Last updated
- 2016-05-02
- Other registries' IDs
- eudract:2011-004889-15
- Results first posted
- 2016-05-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase | Up to 48 weeks | Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (\>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (\<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (\>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was \<=3 at randomization; had a score of \>=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization. |
| Secondary | Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 | DB Baseline (Week 17) and 48 week or DB Endpoint | The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology). |
| Secondary | Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48 | DB Baseline (Week 17) and 48 week or DB Endpoint | The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening. |
| Secondary | Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48 | DB Baseline (Week 17) and 48 week or DB Endpoint | The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100. Participants with a 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. |
| Secondary | Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria | Weeks 41 to 65 | Symptomatic remission criterion was defined as having a simultaneous score of mild or less on all selected PANSS items (P1, P2, P3, N1, N4, N6, G5, and G9). Symptomatic remission was defined for the last 6 months of the Double-blind Phase as meeting the remission criterion during the 6 months prior to the End of study visit during the Double-blind Phase, with one excursion allowed. |
| Secondary | Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 | DB Baseline (Week 17) and 48 week or DB Endpoint | The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology). |
| Secondary | Change From Baseline in Marder Factor Subscale Score at Week 48 | DB Baseline (Week 17) and 48 week or DB Endpoint | 5 PANSS Marder factor scores (positive symptoms \[range:8 to 56\], negative symptoms \[range: 7 to 49\], disorganized thoughts \[range: 7 to 49\], uncontrolled hostility/excitement \[range: 4 to 28\], and anxiety/depression \[range: 4 to 28\]) were examined to gain insight into the symptoms affected by treatment with the study drug. Negative change from baseline in subscales score for positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression indicates improvement in various symptoms of schizophrenia. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase | Up to 48 weeks | Modified intent-to-treat (mITT) analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 | DB Baseline (Week 17) and 48 week or DB Endpoint | mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48 | DB Baseline (Week 17) and 48 week or DB Endpoint | mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48 | DB Baseline (Week 17) and 48 week or DB Endpoint | mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria | Weeks 41 to 65 | mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 | DB Baseline (Week 17) and 48 week or DB Endpoint | mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Marder Factor Subscale Score at Week 48 | DB Baseline (Week 17) and 48 week or DB Endpoint | mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase | Double Blind: Paliperidone Palmitate 3 Month Formulation | 91.5 | Percentage of Participants | ||
| Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase | Double Blind: Paliperidone Palmitate 1 Month Formulation | 90.0 | Percentage of Participants | ||
| Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 | Double Blind: Paliperidone Palmitate 3 Month Formulation | Baseline | 57.4 | Standard Deviation 8.56 | Units on a scale |
| Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 | Double Blind: Paliperidone Palmitate 1 Month Formulation | Baseline | 58.1 | Standard Deviation 8.88 | Units on a scale |
| Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 | Double Blind: Paliperidone Palmitate 3 Month Formulation | Change from Baseline at DB End point | -3.5 | Standard Deviation 12.50 | Units on a scale |
| Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 | Double Blind: Paliperidone Palmitate 1 Month Formulation | Change from Baseline at DB End point | -4.3 | Standard Deviation 11.78 | Units on a scale |
| Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48 | Double Blind: Paliperidone Palmitate 3 Month Formulation | Baseline | 2.9 | Standard Deviation 0.57 | Units on a scale |
| Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48 | Double Blind: Paliperidone Palmitate 1 Month Formulation | Baseline | 2.9 | Standard Deviation 0.66 | Units on a scale |
| Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48 | Double Blind: Paliperidone Palmitate 3 Month Formulation | Change from Baseline at DB End point | -0.1 | Standard Deviation 0.84 | Units on a scale |
| Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48 | Double Blind: Paliperidone Palmitate 1 Month Formulation | Change from Baseline at DB End point | -0.1 | Standard Deviation 0.75 | Units on a scale |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open Label Phase | STARTED | Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation | 1,429 | |
| Open Label Phase | STARTED | Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation | 0 | |
| Open Label Phase | STARTED | Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation | 0 | |
| Open Label Phase | COMPLETED | Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation | 1,016 | |
| Open Label Phase | COMPLETED | Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation | 0 | |
| Open Label Phase | COMPLETED | Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation | 0 | |
| Open Label Phase | NOT COMPLETED | Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation | 413 | |
| Open Label Phase | NOT COMPLETED | Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation | 0 | |
| Open Label Phase | NOT COMPLETED | Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation | 0 | |
| DOUBLE BLIND | STARTED | Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events231
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 | Injection Site Induration | General disorders | Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation | 40 | 1,429 | |
| other | Injection Site Induration | General disorders | Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation | 14 | 504 | |
| other | Injection Site Induration | General disorders | Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation | 6 | 512 | |
| other | Injection Site Pain | General disorders | Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation | 127 | 1,429 | |
| other | Injection Site Pain | General disorders | Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation | 12 | 504 | |
| other | Injection Site Pain | General disorders | Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation | 14 | 512 | |
| other | Nasopharyngitis | Infections and infestations | Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation | 66 | 1,429 | |
| other | Nasopharyngitis | Infections and infestations | Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation | 36 | 504 | |
| other | Nasopharyngitis | Infections and infestations | Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation | 33 | 512 | |
| other | Weight Decreased | Investigations | Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation | 10 | 1,429 |
1 to 10 of 231Source ClinicalTrials.gov
See all 231 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation | ||
| Total, all-cause mortality | Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation | ||
| Total, all-cause mortality | Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation | ||
| Total, other adverse events | Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation | 457 | 1,429 |
| Total, other adverse events | Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation | 212 | 504 |
| Total, other adverse events | Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation | 208 | 512 |
| Total, serious adverse events | Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation | 101 | 1,429 |
| Total, serious adverse events | Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation | 26 | 504 |
| Total, serious adverse events | Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation | 37 | 512 |
Source ClinicalTrials.gov
Papers7
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01515423
GET https://conductscience.org/api/trials/v1/NCT01515423/results?page=2