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UnknownPhase 1

Study of Depakote for Behavioral and Psychological Symptoms in Dementia

An Open-Label Prospective Study of Depakote for Behavioral and Psychological Symptoms in Dementia (BPSD): Use Alone and in Co-Prescription With Atypical Antipsychotic Medications

Asset

Divalproex

Listed sites

1

Recruiting sites

1

Enrollment

20

Study population

Mixed / unspecified dementia

Key I/E criterion

•MMSE ≥7

Primary endpoints

•Change from baseline on CMAI sub-scales•Blood levels of effective dose

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

NCT IDNCT00197834
Org study IDNEIRB05032

Timeline

Milestones

Study start2004-03 (month precision)
Study first posted2005-09-20estimated
Last update posted2006-08-15estimated

Assets

Drug assets

Divalproex

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age60 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) dementia diagnosis
•Age > or = 60 years
•MMSE > 7
•Clinical evidence of a behavioral disturbance as evidenced by nursing staff report or mean score of > 4 on at least one CMAI item
•May be on and remain on co-prescribed psychotropic agents (e.g., antidepressants, atypical antipsychotics, acetylcholinesterase inhibitors)

Exclusion criteria

•Patients with schizophrenia, bipolar disorder, seizure disorder that are co-morbid with dementia
•Patients with delirium, or a poorly controlled medical illness
•MMSE > 24
•Lack of a significant behavioral disturbance
•Low platelet count
•Liver function tests (LFTs) > 2x normal
•Currently on a Depakote formulation or prior unsuccessful trial of Depakote
•Currently on lamotrigine (Lamictal)
•Not currently on but intends to initiate treatment with an acetylcholinesterase inhibitor or memantine during the course of the study.

Endpoints (5)

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
2
Other (unclassified)
2
Safety / tolerability / PK
1

Behavior / neuropsychiatric

2 endpoints
Primary/protocol endpoint

Change from baseline on CMAI sub-scales

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline on CGI and NPI

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Adverse effects and tolerability

descriptive

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Blood levels of effective dose

descriptive

Secondary/protocol endpoint/low confidence

Dosing information on Concomitant psychotropic medications

descriptive

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.