Trial · NCT00412373
Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.
NCT00412373, Phase 3, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2009-12-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder. Trials, record NCT00412373. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00412373
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.
- NCT number
- NCT00412373
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 307 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Schizoaffective Disorder, Psychotic Disorder
- Interventions
- Placebo, Paliperidone ER, Paliperidone ER
- First posted
- 2006-12-18
- Last updated
- 2014-05-09
- Results first posted
- 2009-12-09
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline. | Baseline | The PANSS is a 30-item scale (range 30-210) 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. Higher scores indicate worsening. |
| Primary | Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | The primary efficacy endpoint was the change from baseline to week 6 or the last post-randomization assessment during double-blind treatment in the PANSS total score. | The PANSS is a 30-item scale (range 30-210) 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. Higher scores indicate worsening. |
| Secondary | Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment | Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Higher scores indicate worsening. |
| Secondary | Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment | Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Higher scores indicate worsening. |
| Secondary | Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment | General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Higher scores indicate worsening. |
| Secondary | Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment | Positive PANSS Factor Score (range 8-56): Sum of scores for items 1, 3, 5, and 6 in positive subscale: delusions, hallucinatory behavior, grandiosity, suspiciousness; item 7 in negative subscale: stereotyped thinking; and items 1, 9, and 12 in general psychopathology subscale: somatic concern, unusual thought content, lack of judgment, and insight. Higher scores indicate worsening. |
| Secondary | Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment | Negative PANSS Factor Score (range 7-49): Sum of scores for items 1, 2, 3, 4, and 6 in negative subscale: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity; and items 7 and 16 in general psychopathology subscale: motor retardation, and active social avoidance. Higher scores indicate worsening. |
| Secondary | Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment | Disorganized Thoughts PANSS Factor Score (range 7-49): Sum of scores for item 2 in positive subscale:Conceptual disorganization; item 5 in negative subscale:difficulty in abstract thinking; and items 5, 10, 11, 13, and 15 in general psychopathology subscale: mannerisms/posturing, disorientation, poor attention, disturbance of volition, and preoccupation. Higher scores indicate worsening. |
| Secondary | Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment | Uncontrolled Hostility/Excitement PANSS Factor Score (range 4-28): Sum of scores for items 4 and 7 in positive subscale: excitement, hostility; and items 8 and 14 in general psychopathology subscale: uncooperativeness, and poor impulse control. Higher scores indicate worsening. |
| Secondary | Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment | Anxiety/Depression PANSS Factor Score (range 4-28): Sum of scores for items 2, 3, 4, and 6 in general psychopathology subscale: Anxiety, Guilt feelings, Tension, Depression. Higher scores indicate worsening. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline. | Baseline | The Intent-to-Treat population included all randomly assigned subjects who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment. | points on a scale | MEAN |
| PRIMARY | Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | The primary efficacy endpoint was the change from baseline to week 6 or the last post-randomization assessment during double-blind treatment in the PANSS total score. | The Intent-to-Treat population included all randomly assigned subjects who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment. | points on a scale | MEAN |
| SECONDARY | Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment | Intent-to-Treat | points on a scale | MEAN |
| SECONDARY | Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment | Intent-to-Treat | points on a scale | MEAN |
| SECONDARY | Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment | Intent-to-Treat | points on a scale | MEAN |
| SECONDARY | Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment | Intent-to-Treat | points on a scale | MEAN |
| SECONDARY | Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment | Intent-to-Treat | points on a scale | MEAN |
| SECONDARY | Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment | Intent-to-Treat | points on a scale | MEAN |
| SECONDARY | Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment | Intent-to-Treat | points on a scale | MEAN |
| SECONDARY | Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Change from baseline to Week 6 or the last post-randomization assessment during double-blind treatment | Intent-to-Treat | points on a scale | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline. | Placebo | 91.7 | Standard Deviation 12.1 | points on a scale | |
| Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score at Baseline. | Paliperidone Extended-Release (ER) | 92.3 | Standard Deviation 13.5 | points on a scale | |
| Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Placebo | -10.8 | Standard Deviation 18.7 | points on a scale | |
| Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Paliperidone Extended-Release (ER) | -20.0 | Standard Deviation 18.9 | points on a scale | |
| Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Placebo | -4.6 | Standard Deviation 6.3 | points on a scale | |
| Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Paliperidone Extended-Release (ER) | -7.3 | Standard Deviation 6.9 | points on a scale | |
| Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Placebo | -1.1 | Standard Deviation 5.5 | points on a scale | |
| Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Paliperidone Extended-Release (ER) | -3.0 | Standard Deviation 4.9 | points on a scale | |
| Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Placebo | -5.2 | Standard Deviation 9.4 | points on a scale | |
| Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score - Change From Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point. | Paliperidone Extended-Release (ER) | -9.7 | Standard Deviation 9.9 | points on a scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 93 | |
| Overall Study | STARTED | Paliperidone Extended-Release (ER) | 211 | |
| Overall Study | COMPLETED | Placebo | 52 | |
| Overall Study | COMPLETED | Paliperidone Extended-Release (ER) | 134 | |
| Overall Study | NOT COMPLETED | Placebo | 41 | |
| Overall Study | NOT COMPLETED | Paliperidone Extended-Release (ER) | 77 |
Source ClinicalTrials.gov
Adverse events28
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 | Dyspepsia | Gastrointestinal disorders | Placebo | 5 | 95 | 5 |
| other | Dyspepsia | Gastrointestinal disorders | Paliperidone Extended-Release (ER) | 12 | 214 | 13 |
| other | Akathisia | Nervous system disorders | Placebo | 1 | 95 | 1 |
| other | Akathisia | Nervous system disorders | Paliperidone Extended-Release (ER) | 13 | 214 | 14 |
| other | Dizziness | Nervous system disorders | Placebo | 5 | 95 | 5 |
| other | Dizziness | Nervous system disorders | Paliperidone Extended-Release (ER) | 18 | 214 | 19 |
| other | Headache | Nervous system disorders | Placebo | 12 | 95 | 15 |
| other | Headache | Nervous system disorders | Paliperidone Extended-Release (ER) | 32 | 214 | 38 |
| other | Insomnia | Psychiatric disorders | Placebo | 5 | 95 | 7 |
| other | Insomnia | Psychiatric disorders | Paliperidone Extended-Release (ER) | 14 | 214 | 21 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Paliperidone Extended-Release (ER) | ||
| Total, other adverse events | Placebo | 22 | 95 |
| Total, other adverse events | Paliperidone Extended-Release (ER) | 66 | 214 |
| Total, serious adverse events | Placebo | 8 | 95 |
| Total, serious adverse events | Paliperidone Extended-Release (ER) | 11 | 214 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26934062 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Paliperidone Extended-Release (ER) vs Placebo: Participants With Response | Trial comparisons |
| Paliperidone Extended-Release (ER) vs Placebo: serious adverse events | 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.
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/NCT00412373
GET https://conductscience.org/api/trials/v1/NCT00412373/results?page=2