Clinical Trial Details

NCT ID: NCT00197834
Date Last Changed: August 10, 2006


Research Study Summary

Patients are needed to participate in a clinical research study of Depakote to evaluate Dementia

Research Study Title

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


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.

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Recruitment Details

Both Male and Female
60 and up
Overall Status
Lead Sponsor
Hearthstone Alzheimer Care
Facility Type


Both Male and Female ages 60 Years and up

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.

Site Locations (1)

Country State City Zip Facility and Contact
United States Massachusetts Hopkinton 01748 Hearthstone at Golden Pond
Mark Vanelli, MD
800-378-5454 ext. 0


Joan Hyde, Ph.D.
781-674-2884 ext. 30

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