Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197834
Status:
UNKNOWN
Last Update Posted:
2006-08-15
First Post:
2005-09-12
Brief Title:
Study of Depakote for Behavioral and Psychological Symptoms in Dementia
Sponsor:
Hearthstone Alzheimer Care
Organization:
Hearthstone Alzheimer Care
Study Overview
Official 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
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 either the ER or sprinkle formulation Patients who are suitable for study inclusion will have a score of at least 4 out of 5 with 5 being the most severe on at least one item verbal agitation physical agitation and or aggression of the Cohen-Mansfield Agitation Inventory CMAI short form In this study Depakote ER will be prescribed in addition to existing pharmacotherapy there will be no washout of co-prescribed psychotropic agents The study will not seek to enroll equal numbers of patients on Depakote only vs concomitant treatment Study subjects will be recruited in multiple assisted living nursing home and hospital sites in Massachusetts We anticipate that they will roughly mirror the age gender and other demographic distribution of the larger SCU population This will be a rolling enrollment as patients present with symptoms appropriate for this treatment Our estimate is based on past experience with the referral rates for medication evaluation from these sites Patients currently on atypical antipsychotics who have residual BPSD will be considered for the study as will those on acetylcholinesterase inhibitors Our logic is that as prescribed these agents are not having the desired effect in reducing BPSD Patients who are taking and are appropriate to remain on conventional antipsychotics will be excluded from the study For each enrolled patient we will obtain baseline a psychiatric and medical assessment results of the Mini Mental Status Evaluation MMSE CMAI NPI - NH version and CGI and a nursing staff patient status report prior to beginning psychotropic medication These will be completed at time of study enrollment Patients will then be followed for six weeks with valproic acid levels drawn at weeks 13 and 6 Nursing staff will complete the CMAI at baseline and at weeks 1 3 and 6 Physicians will score patients on the CGI at baseline week 1 3 and 6 and Clinical Raters will complete the NPI at baseline and week 6
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None