Trial · NCT01157351
15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated
NCT01157351, Phase 4, Completed, Janssen Scientific Affairs, LLC; results first posted 2014-12-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated. Trials, record NCT01157351. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01157351
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated
- NCT number
- NCT01157351
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 450 participants, actual
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Conditions
- Schizophrenia
- Interventions
- paliperidone, risperidone, haloperidole, perphenazine, aripiprazole, quetiapine, paliperidone palmitate, olanzapine
- First posted
- 2010-07-07
- Last updated
- 2015-04-24
- Results first posted
- 2014-12-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Treatment Failure | From date of randomization up to Month 15 | Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. |
| Primary | Percentage of Participants in Each Event Category of First Treatment Failure | From date of randomization up to Month 15 | First treatment failure was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation (D/C) of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. Percentage of participants who experienced treatment failure due to any event and for each specific category of event were assessed. |
| Secondary | Time to First Psychiatric Hospitalization or Arrest/Incarceration | From date of randomization up to Month 15 | A time to parameter looking only at 2 component events of treatment failure: arrest or incarceration, and psychiatric hospitalization. An arrest was defined as the taking of a participant into custody by legal authority, for any reason. Incarceration was defined as involuntary confinement by an officer of the law. Psychiatric hospitalization was an inpatient psychiatric hospitalization that occurred due to the participant's clinically significant worsening of symptoms of schizophrenia. |
| Secondary | Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration | Baseline up to Month 15 | The PSP score assesses the degree of difficulty a participant exhibit over a 1 month period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The investigators rate participants' degree of difficulty in each of the 4 domains using a 6-point Likert scale (from 0=absent to 5=very severe). The domain ratings were then transformed to PSP total score ranging from 1 to 100. Higher PSP total scores denote better functioning. A score between 71 and 100 represents normal to mild degree of dysfunction; a score between 31 and 70 represents varying degree of difficulty; and a score \<=30 represents poor function that requires intensive supervision. |
| Secondary | Time to First Psychiatric Hospitalization | From date of randomization up to Month 15 | A time-to parameter looking only at 1 component event of treatment failure: psychiatric hospitalization. Time to first psychiatric hospitalization was admission date of the psychiatric hospitalization recorded in the "Assessment of Treatment Failure - Psychiatric Hospitalization." |
| Secondary | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration | Baseline up to Month 15 | The CGI-S rating scale was a 7-point global assessment of symptom severity with scores determined by clinician as follows: 1=Not ill, 2=Very Mild, 3= Mild, 4= Moderate, 5= Marked, 6= Severe, and 7= Extremely Severe. The higher the score the worse the illness. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Treatment Failure | From date of randomization up to Month 15 | Explanatory Intent-to-Treat (eITT) population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days' supply + 1 day. | Days | MEDIAN |
| SECONDARY | Time to First Psychiatric Hospitalization or Arrest/Incarceration | From date of randomization up to Month 15 | eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days' supply + 1 day. | Days | MEDIAN |
| SECONDARY | Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration | Baseline up to Month 15 | eITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Psychiatric Hospitalization | From date of randomization up to Month 15 | eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days' supply + 1 day. | Days | MEDIAN |
| SECONDARY | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration | Baseline up to Month 15 | eITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants in Each Event Category of First Treatment Failure | From date of randomization up to Month 15 | eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days' supply + 1 day. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Treatment Failure | Paliperidone Palmitate | 416 | 95% Confidence Interval 285 to NA | Days | |
| Time to First Treatment Failure | Oral Antipsychotics | 226 | 95% Confidence Interval 147 to 304 | Days | |
| Time to First Psychiatric Hospitalization or Arrest/Incarceration | Paliperidone Palmitate | NA | 95% Confidence Interval NA to NA | Days | |
| Time to First Psychiatric Hospitalization or Arrest/Incarceration | Oral Antipsychotics | 274 | 95% Confidence Interval 202 to 407 | Days | |
| Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration | Paliperidone Palmitate | 5.75 | Standard Error 0.690 | Units on a scale | |
| Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration | Oral Antipsychotics | 5.36 | Standard Error 0.690 | Units on a scale | |
| Time to First Psychiatric Hospitalization | Paliperidone Palmitate | NA | 95% Confidence Interval NA to NA | Days | |
| Time to First Psychiatric Hospitalization | Oral Antipsychotics | NA | 95% Confidence Interval NA to NA | Days | |
| Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration | Paliperidone Palmitate | -0.48 | Standard Error 0.038 | Units on a scale | |
| Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration | Oral Antipsychotics | -0.43 | Standard Error 0.037 | Units on a scale |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paliperidone Palmitate | 230 | |
| Overall Study | STARTED | Oral Antipsychotics | 220 | |
| Overall Study | Treated | Paliperidone Palmitate | 226 | |
| Overall Study | Treated | Oral Antipsychotics | 218 | |
| Overall Study | COMPLETED | Paliperidone Palmitate | 93 | |
| Overall Study | COMPLETED | Oral Antipsychotics | 88 | |
| Overall Study | NOT COMPLETED | Paliperidone Palmitate | 137 | |
| Overall Study | NOT COMPLETED | Oral Antipsychotics | 132 |
Source ClinicalTrials.gov
Adverse events264
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 | Hyperprolactinaemia | Endocrine disorders | Paliperidone Palmitate | 7 | 226 | |
| other | Hyperprolactinaemia | Endocrine disorders | Oral Antipsychotics | 4 | 218 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Paliperidone Palmitate | 0 | 226 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Oral Antipsychotics | 5 | 218 | |
| other | Constipation | Gastrointestinal disorders | Paliperidone Palmitate | 7 | 226 | |
| other | Constipation | Gastrointestinal disorders | Oral Antipsychotics | 8 | 218 | |
| other | Diarrhoea | Gastrointestinal disorders | Paliperidone Palmitate | 4 | 226 | |
| other | Diarrhoea | Gastrointestinal disorders | Oral Antipsychotics | 7 | 218 | |
| other | Dry Mouth | Gastrointestinal disorders | Paliperidone Palmitate | 15 | 226 | |
| other | Dry Mouth | Gastrointestinal disorders | Oral Antipsychotics | 18 | 218 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paliperidone Palmitate | ||
| Total, all-cause mortality | Oral Antipsychotics | ||
| Total, other adverse events | Paliperidone Palmitate | 178 | 226 |
| Total, other adverse events | Oral Antipsychotics | 155 | 218 |
| Total, serious adverse events | Paliperidone Palmitate | 42 | 226 |
| Total, serious adverse events | Oral Antipsychotics | 53 | 218 |
Source ClinicalTrials.gov
Papers6
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Paliperidone Palmitate vs Oral Antipsychotics: 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.
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/NCT01157351
GET https://conductscience.org/api/trials/v1/NCT01157351/results?page=2