Study of Depakote for Behavioral and Psychological Symptoms in Dementia
Status unconfirmed · Phase 1
Conditions studied: Dementia
In brief
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 and aggression scales over a 6-week period among patients with elevated scores on those scales, and that these positive results can be achieved with fewer side effects than with other agents. In addition, patients will be rated with respect to changes in the Clinical Global Impression (CGI) at baseline, week 1, 3, and 6 and the Neuropsychiatric Inventory (NPI) at baseline and week 6.
Key facts
- Study ID
- NCT00197834
- Run by
- Hearthstone Alzheimer Care
- People needed
- 20
- Starts
- 2004-03-01
- Last updated by the study team
- 2006-08-15
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Hearthstone at Golden Pond — Hopkinton, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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