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TerminatedPhase 3

Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia

Depakote ER vs. Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia

Assets

Divalproex / Quetiapine

Listed sites

1

Recruiting sites

-

Enrollment

20

actual

Study population

Alzheimer’s disease, Vascular cognitive impairment / dementia, Mixed / unspecified dementia

Key I/E criteria

•Multiple dementia etiologies•MMSE ≤23

Primary endpoint

•Cohen-Mansfield Agitation Inventory (CMAI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Secondary ID06-13 Station numberTuscaloosa VA IRB
NCT IDNCT00315900
Org study IDTREAC00081

Timeline

Milestones

Study first posted2006-04-19estimated
Study start2006-05-01actual
Primary completion2007-12-01actual
Study completion2008-02-28actual
Last update posted2017-04-27actual

Assets

Drug assets

DivalproexQuetiapine

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementiaMixed / unspecified dementia

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Veterans
•Males or females
•Aged 55 or older
•With a diagnosis of dementia (either Alzheimer's disease, vascular dementia, or mixed Alzheimer's and vascular dementia)
•Residing in a Tuscaloosa VA Medical Center (TVAMC) NHCU bed
•Admitted to a NHCU bed at Tuscaloosa VA Medical Center
•Score of > 5 on the Functional Assessment Staging (FAST) scale
•Score of < 23 on the Mini-Mental State Examination
•Score of > 1 on the Behavior Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD) global rating
•Total BEHAVE-AD score of > 8
•Agitation present (by history or chart review) for at least two weeks (to minimize chance of enrolling for agitation due to delirium)

Exclusion criteria

•Diagnosis of dementia caused by a condition other than either Alzheimer's disease, vascular dementia, or mixed Alzheimer's and vascular dementia
•History of schizophrenia, bipolar disorder, or schizoaffective disorder
•Untreated depressive or anxiety disorder
•Untreated pain evident on physical examination
•Known allergy or hypersensitivity to either study drug
•History of epilepsy or seizures
•Diagnosis of liver disease or significant abnormalities on liver function tests
•Thrombocytopenia
•Diagnosis or past history of pancreatitis
•Past history of neuroleptic malignant syndrome
•Co-morbid condition that would render tapering off of current antipsychotics or anticonvulsants unsafe
•History of agitation unresponsive to an adequate previous trial of either valproate or quetiapine
•The patient has no identifiable guardian, decision-making proxy, or next of kin to approach for consent to participate.
•The patient's guardian, decision-making proxy, or next of kin withholds, or does not grant, consent to participate
•Patient judged to be too ill to participate

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric
1
Other (unclassified)
1

Behavior / neuropsychiatric

1 endpoint
Primary/protocol endpoint

Cohen-Mansfield Agitation Inventory (CMAI)

Time frame:12 week

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD)

Time frame:12 weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.