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NCT00056498 · ClinicalTrials.gov registry record · Phase 4
Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine
A Phase 4 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 4
- Development phase
- 65
- Enrollment target
NCT00056498: Completed Phase 4 study, sponsored by University of Maryland, Baltimore.
NCT00056498 is a Phase 4 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 65 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00056498, a Phase 4 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 65 participants
- Enrollment target
Study Summary
This study will determine whether adding the drug risperidone (Risperdal®) is more effective than placebo in treating schizophrenic patients who are taking the drug clozapine.
Primary Outcome
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 fol
Interventions
- DRUG Placebo
- DRUG Risperdal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2001-12 |
| Est. Completion | 2007-12 |
| Phase | Phase 4 |
What the finished NCT00056498 record still lists
NCT00056498 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00056498 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00056498 about?
NCT00056498 is a clinical study titled "Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine". This study will determine whether adding the drug risperidone (Risperdal®) is more effective than placebo in treating schizophrenic patients who are taking the drug clozapine.
What is the current status of trial NCT00056498?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 65 participants. The study started on 2001-12. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00056498?
The interventions under investigation include: Placebo (DRUG), Risperdal (DRUG).
Who is sponsoring clinical trial NCT00056498?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00056498's enrollment target sits among peer trials
65 1091st of 2000 higher than 903 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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