Trial · NCT00056498
Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine
NCT00056498, Phase 4, Completed, University of Maryland, Baltimore; results first posted 2012-07-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine. Trials, record NCT00056498. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00056498
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine
- NCT number
- NCT00056498
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 65 participants, actual
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- Schizophrenia
- Interventions
- Placebo, Risperdal
- First posted
- 2003-03-17
- Last updated
- 2019-10-01
- Results first posted
- 2012-07-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Positive Symptom Item Scores by Week and Treatment Group | Baseline and every two weeks for 16 weeks. | The Brief Psychiatric Rating Scale (BPRS) positive symptom items are: conceptual disorganization, hallucinatory behavior, unusual thought content, and suspiciousness. The total score is calculated by adding the scores for each item. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum score is 4 and the maximum score is 28. A higher score indicates a more severe positive symptom rating. A mixed model for unbalanced repeated measures analysis of covariance (ANCOVA), in which follow-up symptom score = baseline symptom score + treatment + week + treatment x week, and week is treated as a categorical, rather than a continuous measure. The treatment term estimates the average across weeks of the week-specific group differences, and is used as the main test for treatment effects on symptom change. |
| Secondary | Neuropsychological Testing - Overall Composite Z-score | Baseline and Week 16 | The neuropsychological testing measured attention, executive function/problem solving, motor speed, processing speed/response generation, and verbal, visual, and working memory. The individual test raw scores were converted to z-scores and an overall composite z-score was computed from the average of the individual test z-scores. Z-scores range from -3 standard deviations up to +3 standard deviations. Higher scores indicate better test performance. |
| Secondary | Negative Symptom Total Score by Week and Treatment Group | Baseline and every two weeks for 16 weeks. | The Scale for the Assessment of Negative Symptoms (SANS) total score, minus the global items, inappropriate affect, poverty of content of speech, and attention items, used to measure negative symptoms. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms. A mixed model for unbalanced repeated measures analysis of covariance (ANCOVA), in which follow-up symptom score = baseline symptom score + treatment + week + treatment x week, and week is treated as a categorical, rather than a continuous measure. The treatment term estimates the average across weeks of the week-specific group differences, and is used as the main test for treatment effects on symptom change. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Positive Symptom Item Scores by Week and Treatment Group | Baseline and every two weeks for 16 weeks. | The intent to treat analysis included all participants who received at least one dose of study medication and completed the BPRS rating at the specified week. | units on a scale | MEAN |
| SECONDARY | Neuropsychological Testing - Overall Composite Z-score | Baseline and Week 16 | Two participants completed 9 or fewer of the 13 individual tests in the neurocognitive battery, and were omitted from calculation of the overall composite score | z-score | MEAN |
| SECONDARY | Negative Symptom Total Score by Week and Treatment Group | Baseline and every two weeks for 16 weeks. | The intent to treat analysis included all participants who received at least one dose of study medication and completed the SANS rating at the specified treatment week. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Positive Symptom Item Scores by Week and Treatment Group | Risperidone | Week 0 | 15.5 | Standard Deviation 3.8 | units on a scale |
| Positive Symptom Item Scores by Week and Treatment Group | Placebo | Week 0 | 15.5 | Standard Deviation 4.2 | units on a scale |
| Positive Symptom Item Scores by Week and Treatment Group | Risperidone | Week 2 | 14.6 | Standard Deviation 3.7 | units on a scale |
| Positive Symptom Item Scores by Week and Treatment Group | Placebo | Week 2 | 15.1 | Standard Deviation 4.0 | units on a scale |
| Positive Symptom Item Scores by Week and Treatment Group | Risperidone | Week 4 | 13.3 | Standard Deviation 4.0 | units on a scale |
| Positive Symptom Item Scores by Week and Treatment Group | Placebo | Week 4 | 14.4 | Standard Deviation 3.5 | units on a scale |
| Positive Symptom Item Scores by Week and Treatment Group | Risperidone | Week 6 | 13.9 | Standard Deviation 3.9 | units on a scale |
| Positive Symptom Item Scores by Week and Treatment Group | Placebo | Week 6 | 14.7 | Standard Deviation 3.8 | units on a scale |
| Positive Symptom Item Scores by Week and Treatment Group | Risperidone | Week 8 | 13.5 | Standard Deviation 4.2 | units on a scale |
| Positive Symptom Item Scores by Week and Treatment Group | Placebo | Week 8 | 14.9 | Standard Deviation 3.9 | units on a scale |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Risperidone | 30 | |
| Overall Study | STARTED | Placebo | 35 | |
| Overall Study | COMPLETED | Risperidone | 25 | |
| Overall Study | COMPLETED | Placebo | 28 | |
| Overall Study | NOT COMPLETED | Risperidone | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 7 |
Source ClinicalTrials.gov
Adverse events6
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 |
|---|---|---|---|---|---|---|
| serious | increased auditory hallucinations | Psychiatric disorders | Risperidone | 1 | 30 | |
| serious | increased auditory hallucinations | Psychiatric disorders | Placebo | 0 | 35 | |
| serious | gastrointestinal symptoms | Gastrointestinal disorders | Risperidone | 0 | 30 | |
| serious | gastrointestinal symptoms | Gastrointestinal disorders | Placebo | 1 | 35 | |
| serious | Panic attack | Psychiatric disorders | Risperidone | 0 | 30 | |
| serious | Panic attack | Psychiatric disorders | Placebo | 1 | 35 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Risperidone | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Risperidone | 0 | 30 |
| Total, other adverse events | Placebo | 0 | 35 |
| Total, serious adverse events | Risperidone | 1 | 30 |
| Total, serious adverse events | Placebo | 2 | 35 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20664583 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01MH045074 | Clozapine Treatment of Schizophrenic Patients | BUCHANAN, ROBERT W | UNIVERSITY OF MARYLAND BALTIMORE | NATIONAL INSTITUTE OF MENTAL HEALTH | 1990 to 2006 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Risperidone vs Placebo: 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.
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