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NCT00308360 · ClinicalTrials.gov registry record · Phase 4
Risperidone Alone Vs. Risperidone Plus Valproate in the Treatment of Patients With Schizophrenia and Hostility
A Phase 4 study, sponsored by Nathan Kline Institute for Psychiatric Research.
- Completed
- Registry status
- Phase 4
- Development phase
- 46
- Enrollment target
NCT00308360 is a Phase 4 study that has completed, run by Nathan Kline Institute for Psychiatric Research. The registered enrollment target is 46 participants.
The verdict
NCT00308360, a Phase 4 study, has completed, sponsored by Nathan Kline Institute for Psychiatric Research.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 46 participants
- Enrollment target
Study Summary
This is an eight-week open-label randomized parallel group clinical trial focusing on the comparison of risperidone alone with risperidone plus valproate among hospitalized adult patients diagnosed with schizophrenia who also exhibit problems with hostility. Patients may have already been receiving risperidone or valproate (but not both) at study entry. Patients not receiving valproate at study entry were randomized to receive either risperidone alone or risperidone with valproate. For patients already receiving valproate at study entry, their antipsychotic medication(s) was switched to risperidone, and they were followed for a four-week lead-in period prior to baseline assessment and randomization to receive risperidone alone or continue with risperidone and valproate. We hypothesized that risperidone alone has an antiaggressive/antihostility effect, and that this effect is augmented by the co-administration of valproate.
Interventions
- DRUG Risperidone, divalproex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 1999-09 |
| Est. Completion | 2004-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00308360
The ClinicalTrials.gov registry entry for NCT00308360 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nathan Kline Institute for Psychiatric Research, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Risperidone, divalproex is the first listed.
NCT00308360 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00308360 about?
NCT00308360 is a clinical study titled "Risperidone Alone Vs. Risperidone Plus Valproate in the Treatment of Patients With Schizophrenia and Hostility". This is an eight-week open-label randomized parallel group clinical trial focusing on the comparison of risperidone alone with risperidone plus valproate among hospitalized adult patients diagnosed with schizophrenia who also exhibit problems with hostility. Patients may have already been receiving ...
What is the current status of trial NCT00308360?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 46 participants. The study started on 1999-09. Estimated completion is 2004-04.
What interventions are being tested in trial NCT00308360?
The interventions under investigation include: Risperidone, divalproex (DRUG).
Who is sponsoring clinical trial NCT00308360?
This trial is sponsored by Nathan Kline Institute for Psychiatric Research, which has 20 total clinical trials registered on ClinicalTrials.gov.
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