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NCT00539071 · ClinicalTrials.gov registry record · Phase 4
High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone
A Phase 4 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 4
- Development phase
- 160
- Enrollment target
NCT00539071: Completed Phase 4 study, sponsored by Northwestern University.
NCT00539071 is a Phase 4 study that has completed, run by Northwestern University. The registered enrollment target is 160 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00539071, a Phase 4 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 160 participants
- Enrollment target
Study Summary
The purpose of this study is to look at two doses of long-acting injectable risperidone (Risperdal Consta). The study will use a usual dose of Risperdal Consta (50 mg given every two weeks) or a higher dose (75 mg-100 mg given every two weeks) to see which one is better at improving symptoms of schizophrenia or schizoaffective disorder.
Primary Outcome
The mean (SEM) of Positive and Negative Syndrome Scale (PANSS) The Positive and Negative Syndrome Scale (PANSS) is a 30-item questionnaire used to assess the severity of symptoms in schizophrenia. It's considered a gold standard for measuring symptom change in antipsychotic trials and other research. The PANSS is divided into three subscales: positive symptoms, negative symptoms, and general psychopathology. Each item is rated on a 7-point scale, ranging from absent to extreme. Therefore, the mi
Interventions
- DRUG long-acting injectable risperidone
- DRUG long acting injectable risperidone, Conventional Dose Group
- DRUG long acting injectable risperidone, High Dose Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2008-03 |
| Est. Completion | 2012-05 |
| Phase | Phase 4 |
What the finished NCT00539071 record still lists
NCT00539071 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 3 interventions - of which long-acting injectable risperidone is the first listed.
NCT00539071 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00539071 about?
NCT00539071 is a clinical study titled "High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone". The purpose of this study is to look at two doses of long-acting injectable risperidone (Risperdal Consta). The study will use a usual dose of Risperdal Consta (50 mg given every two weeks) or a higher dose (75 mg-100 mg given every two weeks) to see which one is better at improving symptoms of schi...
What is the current status of trial NCT00539071?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 160 participants. The study started on 2008-03. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00539071?
The interventions under investigation include: long-acting injectable risperidone (DRUG), long acting injectable risperidone, Conventional Dose Group (DRUG), long acting injectable risperidone, High Dose Group (DRUG).
Who is sponsoring clinical trial NCT00539071?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00539071's enrollment target sits among peer trials
160 507th of 2000 higher than 1,485 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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