Status:
UNKNOWN
Study of Depakote for Behavioral and Psychological Symptoms in Dementia
Lead Sponsor:
Hearthstone Alzheimer Care
Collaborating Sponsors:
Abbott
Conditions:
Dementia
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief Summary
This prospective, naturalistic, open label study will test the hypothesis that Depakote is correlated with a reduction in elevated Cohen-Mansfield Agitation Index (CMAI) verbal and physical agitation ...
Detailed Description
This open label, naturalistic study will enroll a total of 20 patients who are being treated for Behavioral and Psychological Symptoms of Dementia (BPSD), and who are being newly tried on Depakote in ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00197834
Start Date
March 1 2004
Last Update
August 15 2006
Active Locations (1)
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1
Hearthstone at Golden Pond
Hopkinton, Massachusetts, United States, 01748