| City: |
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Hopkinton |
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State:
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MA |
| Zip Code: |
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01748 |
| Conditions: |
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Dementia |
| Purpose: |
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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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| Study summary: |
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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 1,3, 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. |
| Criteria: |
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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. |
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| Study is available at: |
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Hearthstone at Golden Pond
Hopkinton, MA 01748
United States
Primary Contact:
Mark Vanelli, MD
Email: mvanelli@comcast.net
Phone: 800-378-5454
Secondary Contact:
Joan Hyde, Ph.D.
Email: hyde@thehearth.org
Phone: 781-674-2884 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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