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NCT00315900 · ClinicalTrials.gov registry record · Phase 3
Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia
A Phase 3 study, sponsored by Tuscaloosa Research & Education Advancement Corporation.
- Terminated
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
NCT00315900: Clinical Trial Phase 3 study, sponsored by Tuscaloosa Research & Education Advancement Corporation.
NCT00315900 is a Phase 3 study that was terminated before completion, run by Tuscaloosa Research & Education Advancement Corporation. The registered enrollment target is 20 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00315900, a Phase 3 study, was terminated before completion, sponsored by Tuscaloosa Research & Education Advancement Corporation.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
Study Summary
The primary objective of the study is to assess the relative efficacy of Depakote ER and Seroquel for agitated behaviors among veterans with a dementia diagnosis residing in a Department of Veterans Affairs (VA) nursing home care unit (NHCU). The secondary objective of the study is to assess the relative tolerability of Depakote ER and Seroquel in this population. The primary hypothesis is that agitated dementia patients will demonstrate a significantly greater reduction in Cohen-Mansfield Agitation Inventory (CMAI) scores while treated with Depakote ER compared to treatment with Seroquel.
Primary Outcome
Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item scale to systematically assess agitation (higher is more severe).
Interventions
- DRUG Depakote ER
- DRUG Seroquel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2006-05-01 |
| Est. Completion | 2008-02-28 |
| Phase | Phase 3 |
Why NCT00315900 stopped before completion
NCT00315900 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Depakote ER is the first listed.
NCT00315900 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00315900 about?
NCT00315900 is a clinical study titled "Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia". The primary objective of the study is to assess the relative efficacy of Depakote ER and Seroquel for agitated behaviors among veterans with a dementia diagnosis residing in a Department of Veterans Affairs (VA) nursing home care unit (NHCU). The secondary objective of the study is to assess the rel...
What is the current status of trial NCT00315900?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2006-05-01. Estimated completion is 2008-02-28.
What interventions are being tested in trial NCT00315900?
The interventions under investigation include: Depakote ER (DRUG), Seroquel (DRUG).
Who is sponsoring clinical trial NCT00315900?
This trial is sponsored by Tuscaloosa Research & Education Advancement Corporation, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00315900's enrollment target sits among peer trials
20 1956th of 2000 higher than 32 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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