- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00197834
Study of Depakote for Behavioral and Psychological Symptoms in Dementia
August 10, 2006 updated by: Hearthstone Alzheimer Care
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.
Study Overview
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 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.
Study Type
Interventional
Enrollment
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Hopkinton, Massachusetts, United States, 01748
- Recruiting
- Hearthstone at Golden Pond
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Contact:
- Mark Vanelli, MD
- Phone Number: 800-378-5454
- Email: mvanelli@comcast.net
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
58 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change from baseline on CMAI sub-scales
|
Blood levels of effective dose
|
Secondary Outcome Measures
Outcome Measure |
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Change from baseline on CGI and NPI
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Dosing information on Concomitant psychotropic medications
|
Adverse effects and tolerability
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Vanelli, MD, Hearthstone Alzheimer Care
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2004
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
August 15, 2006
Last Update Submitted That Met QC Criteria
August 10, 2006
Last Verified
September 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Dementia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- GABA Agents
- Anticonvulsants
- Antimanic Agents
- Valproic Acid
Other Study ID Numbers
- NEIRB05032
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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