Trial · NCT01662648
Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia
NCT01662648, Phase 3, Completed, Janssen Pharmaceutica; results first posted 2014-03-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia. Trials, record NCT01662648. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01662648
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia
- NCT number
- NCT01662648
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,117 participants, actual
- Lead sponsor
- Janssen Pharmaceutica
- Conditions
- Schizophrenia
- Interventions
- Paliperidone ER
- First posted
- 2012-08-10
- Last updated
- 2014-05-05
- Results first posted
- 2014-03-26
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 | Baseline and Week 26 | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone. |
| Secondary | Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26 | Week 26 | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Percentage of participants with greater than or equal to 20 % improvement in PANSS total score is reported here. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone. |
| Secondary | Change From Baseline in PANSS Total Positive Subscale Score at Week 26 | Baseline and Week 26 | The Positive Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess of or distortion of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone. |
| Secondary | Change From Baseline in PANSS Total Negative Subscale Score at Week 26 | Baseline and Week 26 | The Negative Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone. |
| Secondary | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26 | Baseline and Week 26 | The CGI 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 indicates to "normal, not at all ill" and a rating of 7 indicates "among the most extremely ill participants". Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone. |
| Secondary | Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26 | Baseline and Week 26 | The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone. |
| Secondary | Change From Baseline in Sleep Quality at Week 26 | Baseline and Week 26 | Sleep quality was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how well they have slept in the previous 7 days (from 0: "very badly" to 100: "very well"). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone. |
| Secondary | Change From Baseline in Daytime Drowsiness at Week 26 | Baseline and Week 26 | Daytime Drowsiness was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how often they have felt drowsy within the previous 7 days (from 0: "not at all" to 100:"all the time"). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone. |
| Secondary | Number of Participants Within Each Category of Patient Satisfaction Score | Baseline and Week 26 | Participants were interviewed at baseline and at the end of the trial (Week 26) to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 | Baseline and Week 26 | Intent to Treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26 | Week 26 | ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in PANSS Total Positive Subscale Score at Week 26 | Baseline and Week 26 | ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in PANSS Total Negative Subscale Score at Week 26 | Baseline and Week 26 | ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26 | Baseline and Week 26 | ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26 | Baseline and Week 26 | ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Sleep Quality at Week 26 | Baseline and Week 26 | ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points. | millimeter (mm) | MEAN |
| SECONDARY | Change From Baseline in Daytime Drowsiness at Week 26 | Baseline and Week 26 | ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points. | millimeter (mm) | MEAN |
| SECONDARY | Number of Participants Within Each Category of Patient Satisfaction Score | Baseline and Week 26 | ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure and n signifies those participants who were evaluated for this measure at specified time point. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 | Paliperidone ER: Lack of Efficacy | Baseline | 85.19 | Standard Deviation 24.97 | units on a scale |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 | Paliperidone ER: Lack of Tolerability, Compliance or Other | Baseline | 65.45 | Standard Deviation 28.48 | units on a scale |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 | Paliperidone ER: Lack of Efficacy | Week 26 | -26.60 | Standard Deviation 28.24 | units on a scale |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 | Paliperidone ER: Lack of Tolerability, Compliance or Other | Week 26 | -20.52 | Standard Deviation 30.05 | units on a scale |
| Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26 | Paliperidone ER: Lack of Efficacy | 72.83 | percentage of participants | ||
| Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26 | Paliperidone ER: Lack of Tolerability, Compliance or Other | 71.87 | percentage of participants | ||
| Change From Baseline in PANSS Total Positive Subscale Score at Week 26 | Paliperidone ER: Lack of Efficacy | Baseline | 21.04 | Standard Deviation 7.15 | units on a scale |
| Change From Baseline in PANSS Total Positive Subscale Score at Week 26 | Paliperidone ER: Lack of Tolerability, Compliance or Other | Baseline | 15.26 | Standard Deviation 7.53 | units on a scale |
| Change From Baseline in PANSS Total Positive Subscale Score at Week 26 | Paliperidone ER: Lack of Efficacy | Week 26 | -7.17 | Standard Deviation 7.67 | units on a scale |
| Change From Baseline in PANSS Total Positive Subscale Score at Week 26 | Paliperidone ER: Lack of Tolerability, Compliance or Other | Week 26 | -5.07 | Standard Deviation 7.88 | units on a scale |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paliperidone ER: Lack of Efficacy | 520 | |
| Overall Study | STARTED | Paliperidone ER: Lack of Tolerability, Compliance or Other | 597 | |
| Overall Study | COMPLETED | Paliperidone ER: Lack of Efficacy | 373 | |
| Overall Study | COMPLETED | Paliperidone ER: Lack of Tolerability, Compliance or Other | 419 | |
| Overall Study | NOT COMPLETED | Paliperidone ER: Lack of Efficacy | 147 | |
| Overall Study | NOT COMPLETED | Paliperidone ER: Lack of Tolerability, Compliance or Other | 178 |
Source ClinicalTrials.gov
Adverse events148
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 | Extrapyramidal disorder | Nervous system disorders | Paliperidone ER: Lack of Efficacy | 34 | 512 | |
| other | Extrapyramidal disorder | Nervous system disorders | Paliperidone ER: Lack of Tolerability, Compliance or Other | 21 | 587 | |
| other | Headache | Nervous system disorders | Paliperidone ER: Lack of Efficacy | 23 | 512 | |
| other | Headache | Nervous system disorders | Paliperidone ER: Lack of Tolerability, Compliance or Other | 24 | 587 | |
| other | Dizziness | Nervous system disorders | Paliperidone ER: Lack of Efficacy | 16 | 512 | |
| other | Dizziness | Nervous system disorders | Paliperidone ER: Lack of Tolerability, Compliance or Other | 22 | 587 | |
| other | Akathisia | Nervous system disorders | Paliperidone ER: Lack of Efficacy | 13 | 512 | |
| other | Akathisia | Nervous system disorders | Paliperidone ER: Lack of Tolerability, Compliance or Other | 18 | 587 | |
| other | Somnolence | Nervous system disorders | Paliperidone ER: Lack of Efficacy | 9 | 512 | |
| other | Somnolence | Nervous system disorders | Paliperidone ER: Lack of Tolerability, Compliance or Other | 20 | 587 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paliperidone ER: Lack of Efficacy | ||
| Total, all-cause mortality | Paliperidone ER: Lack of Tolerability, Compliance or Other | ||
| Total, other adverse events | Paliperidone ER: Lack of Efficacy | 208 | 512 |
| Total, other adverse events | Paliperidone ER: Lack of Tolerability, Compliance or Other | 239 | 587 |
| Total, serious adverse events | Paliperidone ER: Lack of Efficacy | 35 | 512 |
| Total, serious adverse events | Paliperidone ER: Lack of Tolerability, Compliance or Other | 29 | 587 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Paliperidone ER: Lack of Efficacy vs Paliperidone ER: Lack of Tolerability, Compliance or Other: serious adverse events |
Source Trial comparisons
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.
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