DementiaPhase 1NCT00197834
Study of Depakote for Behavioral and Psychological Symptoms in Dementia
A Phase 1 study testing Depakote in people with Dementia, run by Hearthstone Alzheimer Care at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Depakote
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hearthstone at Golden Pond
Hopkinton, Massachusetts, 01748
Mark Vanelli, MD, 800-378-5454 ext. 0, mvanelli@comcast.net
About this study
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
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Depakote
- Keywords
- Depakote, Agitation, Dementia, Atypical antipsychotic, Behavioral Symptoms, Psychiatric Symptoms, Psychological Symptoms, Geriatric, Behavioral and Psychological Symptoms
- Medical subject headings
- Dementia, Psychomotor Agitation, Behavioral Symptoms, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepakoteDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on CMAI sub-scales
Blood levels of effective dose
Secondary outcomes (3)
Change from baseline on CGI and NPI
Dosing information on Concomitant psychotropic medications
Adverse effects and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Hearthstone Alzheimer Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Abbott
- Investigators
- Mark Vanelli, MD, Principal investigator, Hearthstone Alzheimer Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197834
- Sponsor's protocol ID
- NEIRB05032
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 15 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00197834
- Acronym / sponsor ID
- NEIRB05032
- Conditions
- Dementia
- Keywords
- Depakote, Agitation, Dementia, Atypical antipsychotic, Behavioral Symptoms, Psychiatric Symptoms, Psychological Symptoms, Geriatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Hearthstone Alzheimer CareIndustry (pharma, biotech, devices)
- Collaborators
- Abbott
- Study start
- Mar 2004
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depakote | Drug | – |
Primary outcome
Change from baseline on CMAI sub-scales
Blood levels of effective dose
3 secondary outcomes
Change from baseline on CGI and NPI
Dosing information on Concomitant psychotropic medications
Adverse effects and tolerability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Vanelli, MD principal investigator
Hearthstone Alzheimer Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Depakote in people with Dementia, run by Hearthstone Alzheimer Care at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joan Hyde, Ph.D. (781-674-2884 ext. 30, hyde@thehearth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on CMAI sub-scales. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2006.