Study of Depakote for Behavioral and Psychological Symptoms in Dementia (NCT00197834) | Clinical Trial Compass
UnknownPhase 1
Study of Depakote for Behavioral and Psychological Symptoms in Dementia
United States20 participantsStarted 2004-03
Plain-language 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 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.