Trial · NCT00256997
A Study of Risperidone Long-Acting Injection Versus Oral Antipsychotics in Schizophrenia Participants With a History of Being Poorly Compliant With Taking Their Medication
NCT00256997, Phase 4, Terminated, Janssen-Ortho Inc., Canada; results first posted 2013-10-07
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ConductScience Library. A Study of Risperidone Long-Acting Injection Versus Oral Antipsychotics in Schizophrenia Participants With a History of Being Poorly Compliant With Taking Their Medication. Trials, record NCT00256997. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00256997
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Risperidone Long-Acting Injection Versus Oral Antipsychotics in Schizophrenia Participants With a History of Being Poorly Compliant With Taking Their Medication
- NCT number
- NCT00256997
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 167 participants, actual
- Lead sponsor
- Janssen-Ortho Inc., Canada
- Conditions
- Schizophrenia
- Interventions
- Risperidone long-acting injection (LAI), Oral atypical Antipsychotic
- First posted
- 2005-11-22
- Last updated
- 2013-12-05
- Results first posted
- 2013-10-07
- Limitations and caveats
- The study was terminated due to futility.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization | Month 3 up to Month 24 | Clinical exacerbation is defined as hospitalization because of participant's schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, delusions, hallucinations, and self withdrawal) or requiring change from current antipsychotic or initiation of adjunctive antipsychotic, 2-point worsening in Clinical Global Impression of Severity (CGI-S) or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control. |
| Secondary | Percentage of Participants Who Experienced a Clinical Exacerbation | Baseline up to Month 24 | Clinical exacerbation is defined as hospitalization because of participant's schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control. |
| Secondary | Time to First Clinical Exacerbation | Baseline up to Month 24 | Time to first clinical exacerbation was calculated over the entire trial duration wherein clinical exacerbation is defined as hospitalization because of participant's schizophrenia or requiring change from current antipsychotic or initiation of an adjunctive antipsychotic, 2-point worsening in CGI-S or emergency room visit, deliberate self-injury, emergence of clinically significant suicidal ideation, utilization of treatment team services, violent behavior, requiring an increase in dose of existing antipsychotic as a result of poor symptom control. |
| Secondary | Time in Symptomatic (Having Symptoms) Remission | Baseline up to Month 24 | Time in symptomatic (having symptoms) remission for participants on risperidone was compared with those on oral atypical medication and was calculated over the entire trial duration. |
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24 | Baseline and Month 24 | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) 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. |
| Secondary | Number of Participants With Clinical Global Impression of Severity (CGI-S) | Baseline and End of Study (Month 24 or Early Withdrawal [EW]) | The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening. |
| Secondary | Number of Participants With Clinical Global Impression of Change (CGI-C) | End of Study (Month 24 or Early Withdrawal [EW]) | The CGI-C is a assessment of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening. |
| Secondary | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Baseline up to Month 24 | This questionnaire included questions asked to participants about any hospitalizations, visits to the emergency room or any other psychiatric treatment received in the previous month. Also the participants and/or primary health care contact or caregiver (or other modality to obtain accurate information) were telephoned on a monthly basis (1 month post Visit 2 through to end of study \[Visit 6, Month 24\]) by a member of the investigational staff and the resource utilization assessment was conducted over the phone. |
| Secondary | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Baseline and Month 24 | AQoL is defined as an Australian-developed participant delivered quality of life (QoL) instrument consisting of 15-questions in 5 scales measuring illness, independence, social relationships, physical senses and psychological well-being. Each of the 5 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 \[worst\] to 1 \[best\] and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health). The scores for independent living, social relationships, physical senses and psychological well-being are combined to obtain the QoL utility score which refers to the "value" of a health state to the respondent where the lower boundary is -0.04 (representing QoL state worse than death), 0.00 (death equivalent QoL state) and to 1.00 (best possible QoL state)". |
| Secondary | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24 | Baseline and End of Study (Month 24 or Early Termination [ET]) | The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization | Month 3 up to Month 24 | Intent-to-treat (ITT) population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced a Clinical Exacerbation | Baseline up to Month 24 | ITT population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. | Percentage of participants | NUMBER |
| SECONDARY | Time to First Clinical Exacerbation | Baseline up to Month 24 | ITT population included all participants who received medication with at least one post-baseline effectiveness measure. Here, 'N' signifies number of participants evaluated for this outcome measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. | Months | MEAN |
| SECONDARY | Time in Symptomatic (Having Symptoms) Remission | Baseline up to Month 24 | Data for this outcome was not computed as it was not defined in terms of the formula for calculation and thus was not included in analysis plan. | ||
| SECONDARY | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24 | Baseline and Month 24 | ITT population. Here, 'N' signifies number of participants evaluated for this outcome measure. 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. | Units on a scale | MEAN |
| SECONDARY | Number of Participants With Clinical Global Impression of Severity (CGI-S) | Baseline and End of Study (Month 24 or Early Withdrawal [EW]) | ITT population. Here, 'N' signifies number of participants evaluated for this outcome measure. 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. | participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Global Impression of Change (CGI-C) | End of Study (Month 24 or Early Withdrawal [EW]) | ITT population included all participants who received medication with at least one post-baseline effectiveness measure. Here, 'N' signifies number of participants evaluated for this outcome measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. | Participants | NUMBER |
| SECONDARY | Number of Participants With Response to Resource Utilization Questionnaire (RUQ) | Baseline up to Month 24 | ITT population included all participants who received medication with at least one post-baseline effectiveness measure. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Assessment of Quality of Life (AQoL) Score at Month 24 | Baseline and Month 24 | ITT population. Here 'N' signifies number of participants evaluated for this outcome measure and 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score at Month 24 | Baseline and End of Study (Month 24 or Early Termination [ET]) | ITT population. Here 'N' signifies number of participants evaluated for this outcome measure and 'n' signifies number of participants who were evaluated for this outcome measure at given timepoint. This study was stopped due to futility; care must be exercised in any interpretation of utilization of these data. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization | Risperidone Long-Acting Injection (LAI) | 48.1 | Percentage of participants | ||
| Percentage of Participants Who Experienced a Clinical Exacerbation From Month 3 Post-Randomization | Oral Atypical Antipsychotic | 43.0 | Percentage of participants | ||
| Percentage of Participants Who Experienced a Clinical Exacerbation | Risperidone Long-acting Injection (LAI) | 54.4 | Percentage of participants | ||
| Percentage of Participants Who Experienced a Clinical Exacerbation | Oral Atypical Antipsychotic | 54.7 | Percentage of participants | ||
| Time to First Clinical Exacerbation | Risperidone Long-acting Injection (LAI) | 10.4 | Standard Error 0.80 | Months | |
| Time to First Clinical Exacerbation | Oral Atypical Antipsychotic | 11.2 | Standard Error 0.93 | Months | |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24 | Risperidone Long-acting Injection (LAI) | Baseline (n=79, 85) | 77.6 | Standard Deviation 17.24 | Units on a scale |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24 | Oral Atypical Antipsychotic | Baseline (n=79, 85) | 76.5 | Standard Deviation 17.83 | Units on a scale |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24 | Risperidone Long-acting Injection (LAI) | Change at Month 24: Total score (n=67, 67) | -9.6 | Standard Deviation 19.80 | Units on a scale |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Month 24 | Oral Atypical Antipsychotic | Change at Month 24: Total score (n=67, 67) | -12.4 | Standard Deviation 21.83 | Units on a scale |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Risperidone Long-Acting Injection (LAI) | 81 | |
| Overall Study | STARTED | Oral Atypical Antipsychotic | 86 | |
| Overall Study | Treated | Risperidone Long-Acting Injection (LAI) | 79 | |
| Overall Study | Treated | Oral Atypical Antipsychotic | 86 | |
| Overall Study | COMPLETED | Risperidone Long-Acting Injection (LAI) | 33 | |
| Overall Study | COMPLETED | Oral Atypical Antipsychotic | 31 | |
| Overall Study | NOT COMPLETED | Risperidone Long-Acting Injection (LAI) | 48 | |
| Overall Study | NOT COMPLETED | Oral Atypical Antipsychotic | 55 |
Source ClinicalTrials.gov
Adverse events646
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 | Anaemia | Blood and lymphatic system disorders | Risperidone Long-Acting Injection (LAI) | 1 | 81 | |
| other | Anaemia | Blood and lymphatic system disorders | Oral Atypical Antipsychotic | 1 | 86 | |
| other | Arrhythmia | Cardiac disorders | Risperidone Long-Acting Injection (LAI) | 0 | 81 | |
| other | Arrhythmia | Cardiac disorders | Oral Atypical Antipsychotic | 1 | 86 | |
| other | Bradycardia | Cardiac disorders | Risperidone Long-Acting Injection (LAI) | 1 | 81 | |
| other | Bradycardia | Cardiac disorders | Oral Atypical Antipsychotic | 0 | 86 | |
| other | Extrasystoles | Cardiac disorders | Risperidone Long-Acting Injection (LAI) | 1 | 81 | |
| other | Extrasystoles | Cardiac disorders | Oral Atypical Antipsychotic | 0 | 86 | |
| other | Palpitations | Cardiac disorders | Risperidone Long-Acting Injection (LAI) | 1 | 81 | |
| other | Palpitations | Cardiac disorders | Oral Atypical Antipsychotic | 1 | 86 |
1 to 10 of 646Source ClinicalTrials.gov
See all 646 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Risperidone Long-Acting Injection (LAI) | ||
| Total, all-cause mortality | Oral Atypical Antipsychotic | ||
| Total, other adverse events | Risperidone Long-Acting Injection (LAI) | 70 | 81 |
| Total, other adverse events | Oral Atypical Antipsychotic | 69 | 86 |
| Total, serious adverse events | Risperidone Long-Acting Injection (LAI) | 14 | 81 |
| Total, serious adverse events | Oral Atypical Antipsychotic | 6 | 86 |
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 |
|---|
| Risperidone Long-Acting Injection (LAI) vs Oral Atypical Antipsychotic: 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/NCT00256997
GET https://conductscience.org/api/trials/v1/NCT00256997/results?page=2