Trial · NCT00216476
A Study of Relapse Prevention and the Effectiveness of Long-acting Injectable Risperidone and Quetiapine Tablets in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
NCT00216476, Phase 3, Completed, Janssen-Cilag International NV; results first posted 2010-08-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Relapse Prevention and the Effectiveness of Long-acting Injectable Risperidone and Quetiapine Tablets in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder. Trials, record NCT00216476. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00216476
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Relapse Prevention and the Effectiveness of Long-acting Injectable Risperidone and Quetiapine Tablets in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
- NCT number
- NCT00216476
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 753 participants, actual
- Lead sponsor
- Janssen-Cilag International NV
- Conditions
- Schizophrenia, Psychotic Disorders
- Interventions
- Aripiprazole, Risperidone Long Acting Injectable (LAI), Quetiapine
- First posted
- 2005-09-22
- Last updated
- 2014-04-16
- Results first posted
- 2010-08-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Relapse Free Period(Risperidone LAI Versus Quetiapine) | Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier) | Relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. The relapse rate in each treatment arm was estimated using the Kaplan-Meier method. |
| Secondary | Mean Relapse Free Period (Exploratory/Aripiprazole) | Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier) | As for risperidone and quetiapine, relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. Since aripiprazole was new on the market at the time the study was conducted, this aripiprazole analysis was exploratory. |
| Secondary | Change From Baseline to Endpoint in Total Positive and Negative Syndrome Scale (PANSS) Score | Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier) | The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item PANSS scale. The PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, i.e., the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). |
| Secondary | Change From Baseline to Endpoint in Clinical Global Impression Scale (CGI) Score | Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Month 24 or earlier) | The 7-point CGI scale of Severity (CGI-S) was used to assess the severity of a subject's psychotic condition (0= normal, not at all ill, 1= borderline, etc. and 6= among the most extremely ill subjects). |
| Secondary | Change From Baseline to Endpoint in Short-Form Health Survey 12 (SF-12) Scores | Assessed at the moment the subject was randomized to a treatment arm (baseline visit) and after 1, 3, 6, 12, 18, and 24 months of treatment | Quality of life was assessed by means of the 12-item SF-12® survey. Two parameters, i.e., PCS (physical component summary) and MCS (mental component summary) were calculated. Both components scores range from 0 to 100 with higher scores indicating better QOL. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Relapse Free Period(Risperidone LAI Versus Quetiapine) | Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier) | Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and who had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI arm and 11 of the quetiapine arm. | days | MEAN |
| SECONDARY | Mean Relapse Free Period (Exploratory/Aripiprazole) | Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier) | Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and who had at least 1 efficacy assessment after baseline. This excluded 1 subject of the aripiprazole arm. | days | MEAN |
| SECONDARY | Change From Baseline to Endpoint in Total Positive and Negative Syndrome Scale (PANSS) Score | Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier) | Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI, 11 of the quetipaine, and 1 of the aripiprazole arm. One additional subject in each the risperidone LAI and quetiapine arm did not have PANSS data. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Endpoint in Clinical Global Impression Scale (CGI) Score | Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Month 24 or earlier) | Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI arm, 11 of the quetipaine arm, and 1 of the aripiprazole arm. One additional subject in the risperidone LAI arm did not have CGI data. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Endpoint in Short-Form Health Survey 12 (SF-12) Scores | Assessed at the moment the subject was randomized to a treatment arm (baseline visit) and after 1, 3, 6, 12, 18, and 24 months of treatment | Efficacy analysis set, defined as all subjects who received at least 1 dose of study medication and had at least 1 efficacy assessment after baseline. This excluded 2 subjects of the risperidone LAI, 11 of the quetipaine, and 1 of the aripiprazole arm. An additional 32, 32, and 2 subjects in the respective arms did not have SF-12 data. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Relapse Free Period(Risperidone LAI Versus Quetiapine) | Risperidone LAI | 607 | Standard Deviation 11.4 | days | |
| Mean Relapse Free Period(Risperidone LAI Versus Quetiapine) | Quetiapine | 533 | Standard Deviation 15.6 | days | |
| Mean Relapse Free Period (Exploratory/Aripiprazole) | Aripiprazole | 314 | Standard Error 20.4 | days | |
| Change From Baseline to Endpoint in Total Positive and Negative Syndrome Scale (PANSS) Score | Risperidone LAI | -9.3 | Standard Deviation 25.65 | units on a scale | |
| Change From Baseline to Endpoint in Total Positive and Negative Syndrome Scale (PANSS) Score | Quetiapine | -1.1 | Standard Deviation 26.28 | units on a scale | |
| Change From Baseline to Endpoint in Total Positive and Negative Syndrome Scale (PANSS) Score | Aripiprazole | -7.7 | Standard Deviation 27.99 | units on a scale | |
| Change From Baseline to Endpoint in Clinical Global Impression Scale (CGI) Score | Risperidone LAI | -0.3 | Standard Deviation 1.25 | units on a scale | |
| Change From Baseline to Endpoint in Clinical Global Impression Scale (CGI) Score | Quetiapine | 0.1 | Standard Deviation 1.24 | units on a scale | |
| Change From Baseline to Endpoint in Clinical Global Impression Scale (CGI) Score | Aripiprazole | -0.1 | Standard Deviation 1.32 | units on a scale | |
| Change From Baseline to Endpoint in Short-Form Health Survey 12 (SF-12) Scores | Risperidone LAI | PCS score | 2.1 | Standard Deviation 9.04 | units on a scale |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Risperidone LAI | 329 | |
| Overall Study | STARTED | Quetiapine | 337 | |
| Overall Study | STARTED | Aripiprazole | 45 | |
| Overall Study | COMPLETED | Risperidone LAI | 224 | |
| Overall Study | COMPLETED | Quetiapine | 230 | |
| Overall Study | COMPLETED | Aripiprazole | 28 | |
| Overall Study | NOT COMPLETED | Risperidone LAI | 105 | |
| Overall Study | NOT COMPLETED | Quetiapine | 107 | |
| Overall Study | NOT COMPLETED | Aripiprazole | 17 |
Source ClinicalTrials.gov
Adverse events294
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 | Anxiety | Psychiatric disorders | Risperidone LAI | 39 | 329 | |
| other | Anxiety | Psychiatric disorders | Quetiapine | 30 | 337 | |
| other | Anxiety | Psychiatric disorders | Aripiprazole | 7 | 45 | |
| other | Asthenia | General disorders | Risperidone LAI | 2 | 329 | |
| other | Asthenia | General disorders | Quetiapine | 11 | 337 | |
| other | Asthenia | General disorders | Aripiprazole | 3 | 45 | |
| other | Delusion | Psychiatric disorders | Risperidone LAI | 4 | 329 | |
| other | Delusion | Psychiatric disorders | Quetiapine | 4 | 337 | |
| other | Delusion | Psychiatric disorders | Aripiprazole | 4 | 45 | |
| other | Depression | Psychiatric disorders | Risperidone LAI | 15 | 329 |
1 to 10 of 294Source ClinicalTrials.gov
See all 294 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Risperidone LAI | ||
| Total, all-cause mortality | Quetiapine | ||
| Total, all-cause mortality | Aripiprazole | ||
| Total, other adverse events | Risperidone LAI | 201 | 329 |
| Total, other adverse events | Quetiapine | 213 | 337 |
| Total, other adverse events | Aripiprazole | 28 | 45 |
| Total, serious adverse events | Risperidone LAI | 63 | 329 |
| Total, serious adverse events | Quetiapine | 77 | 337 |
| Total, serious adverse events | Aripiprazole | 7 | 45 |
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 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/NCT00216476
GET https://conductscience.org/api/trials/v1/NCT00216476/events?page=2