AgitationPhase 3NCT00315900
Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia
A Phase 3 study testing Depakote ER and Seroquel in people with Agitation and Dementia, run by Tuscaloosa Research & Education Advancement Corporation at 1 site in United States.
Trial summary
The primary objective of the study is to assess the relative efficacy of Depakote ER and Seroquel for agitated behaviors among veterans with a dementia diagnosis residing in a Department of Veterans Affairs (VA) nursing home care unit (NHCU). Read more about this study
- Who is it for?
- Ages 55 years and older
- What is being tested?
- Depakote ER and Seroquel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2006to 28 Feb 2008
- Phase
- Phase 3
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans
- Males or females
- Aged 55 or older
- With a diagnosis of dementia (either Alzheimer's disease, vascular dementia, or mixed Alzheimer's and vascular dementia)
- Residing in a Tuscaloosa VA Medical Center (TVAMC) NHCU bed
- Admitted to a NHCU bed at Tuscaloosa VA Medical Center
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- Score of > 5 on the Functional Assessment Staging (FAST) scale
- Score of < 23 on the Mini-Mental State Examination
- Score of > 1 on the Behavior Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD) global rating
- Total BEHAVE-AD score of > 8
- Agitation present (by history or chart review) for at least two weeks (to minimize chance of enrolling for agitation due to delirium).
Who cannot join
- Diagnosis of dementia caused by a condition other than either Alzheimer's disease, vascular dementia, or mixed Alzheimer's and vascular dementia
- History of schizophrenia, bipolar disorder, or schizoaffective disorder
- Untreated depressive or anxiety disorder
- Untreated pain evident on physical examination
- Known allergy or hypersensitivity to either study drug
- History of epilepsy or seizures
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- Diagnosis of liver disease or significant abnormalities on liver function tests
- Thrombocytopenia
- Diagnosis or past history of pancreatitis
- Past history of neuroleptic malignant syndrome
- Co-morbid condition that would render tapering off of current antipsychotics or anticonvulsants unsafe
- History of agitation unresponsive to an adequate previous trial of either valproate or quetiapine
- The patient has no identifiable guardian, decision-making proxy, or next of kin to approach for consent to participate.
- The patient's guardian, decision-making proxy, or next of kin withholds, or does not grant, consent to participate
- Patient judged to be too ill to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, 35404
About this study
Official title: Depakote ER vs. Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia
The primary objective of the study is to assess the relative efficacy of Depakote ER and Seroquel for agitated behaviors among veterans with a dementia diagnosis residing in a Department of Veterans Affairs (VA) nursing home care unit (NHCU). The secondary objective of the study is to assess the relative tolerability of Depakote ER and Seroquel in this population. The primary hypothesis is that agitated dementia patients will demonstrate a significantly greater reduction in Cohen-Mansfield Agitation Inventory (CMAI) scores while treated with Depakote ER compared to treatment with Seroquel.
Read the detailed description
This study is a prospective, single-center, randomized, double-blind, double-dummy, crossover trial of Depakote ER vs. Seroquel for agitated behaviors among veterans with dementia. After consent is obtained and after a washout period of one week or five half-lives after taper (if necessary), 20 eligible patients will be randomized to received one of two treatments. The first is DEPAKOTE ER, initiated at 250 mg daily. The other treatment will be Seroquel, starting at 25 mg BID. Both treatments will be co-administered with a placebo that matches the other drug (to preserve blinding). Using serial examinations and blinded laboratory reporting, doses will be adjusted to clinical response or to achieve a serum valproate level of at least 50 mcg/mL. After a treatment period of six weeks, patients will be crossed over to the other treatment without washout (doses will be adjusted concurrently) for a second six-week treatment period. The Cohen-Mansfield Agitation Inventory (CMAI) will be the primary outcome measure. Secondary measures include the Behavior Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD); Clinical Global Impression Scale - Severity; Clinical Global Impression Scale - Improvement; Barnes Akathisia Scale (BAS); and the Abnormal Involuntary Movements Scale (AIMS). Outcome measures will be performed at the end of each six-week treatment period to avoid carryover effects.
- Being tested
- Depakote ER, Seroquel
- Keywords
- Seroquel, Depakote ER, Nursing Home, Quetiapine, Divalproex ER, Agitation
- Medical subject headings
- Psychomotor Agitation, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depakote ERDrug
Also called Divalproex
depakote ER
SeroquelDrug
Also called quetiapine
seroquel
| Study group | Role | What they receive |
|---|---|---|
| Depakote ER | Experimental | Depakote ER Receives: Drug: Depakote ER |
| Seroquel | Active comparator | Seroquel Receives: Drug: Seroquel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohen-Mansfield Agitation Inventory (CMAI)
Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item scale to systematically assess agitation (higher is more severe).
Measured: 12 week
Secondary outcomes (1)
Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD)
A psychiatric rating scale to evaluate behavioral disturbances in dementia patients. assesses 25 potentially remediable behavioral symptoms on a 4-rating-point severity scale (higher score is more severe).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2006 (estimated)
- Study start1 May 2006
- Primary completion1 Dec 2007
- Study completion28 Feb 2008
Why it stopped: Investigator closed study and left VAMC.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgitationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuscaloosa Research & Education Advancement Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
- Investigators
- John L Shuster, MD, Principal investigator, Tuscaloosa Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315900
- Sponsor's protocol ID
- TREAC00081
- Other IDs
- 06-13 Station number
- Status last verified
- Apr 2017
- First submitted
- 17 Apr 2006
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shuster JL Jr. Palliative care for advanced dementia. Clin Geriatr Med. 2000 May;16(2):373-86. doi: 10.1016/s0749-0690(05)70062-8.
PubMed 10783434
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depakote ER vs. Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia
- ClinicalTrials.gov ID
- NCT00315900
- Acronym / sponsor ID
- TREAC00081
- Keywords
- Seroquel, Depakote ER, Nursing Home, Quetiapine, Divalproex ER, Agitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator closed study and left VAMC.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tuscaloosa Research & Education Advancement CorporationUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 1 May 2006 (actual)
- Primary completion
- 1 Dec 2007 (actual)
- Study completion
- 28 Feb 2008 (actual)
- First posted
- 19 Apr 2006 (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.
The primary objective of the study is to assess the relative efficacy of Depakote ER and Seroquel for agitated behaviors among veterans with a dementia diagnosis residing in a Department of Veterans Affairs (VA) nursing home care unit (NHCU). The secondary objective of the study is to assess the relative tolerability of Depakote ER and Seroquel in this population. The primary hypothesis is that agitated dementia patients will demonstrate a significantly greater reduction in Cohen-Mansfield Agitation Inventory (CMAI) scores while treated with Depakote ER compared to treatment with Seroquel.
Detailed description
This study is a prospective, single-center, randomized, double-blind, double-dummy, crossover trial of Depakote ER vs. Seroquel for agitated behaviors among veterans with dementia. After consent is obtained and after a washout period of one week or five half-lives after taper (if necessary), 20 eligible patients will be randomized to received one of two treatments. The first is DEPAKOTE ER, initiated at 250 mg daily. The other treatment will be Seroquel, starting at 25 mg BID. Both treatments will be co-administered with a placebo that matches the other drug (to preserve blinding). Using serial examinations and blinded laboratory reporting, doses will be adjusted to clinical response or to achieve a serum valproate level of at least 50 mcg/mL. After a treatment period of six weeks, patients will be crossed over to the other treatment without washout (doses will be adjusted concurrently) for a second six-week treatment period. The Cohen-Mansfield Agitation Inventory (CMAI) will be the primary outcome measure. Secondary measures include the Behavior Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD); Clinical Global Impression Scale - Severity; Clinical Global Impression Scale - Improvement; Barnes Akathisia Scale (BAS); and the Abnormal Involuntary Movements Scale (AIMS). Outcome measures will be performed at the end of each six-week treatment period to avoid carryover effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depakote ER | Experimental | Drug: Depakote ERDepakote ER |
| Seroquel | Active comparator | Drug: SeroquelSeroquel |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Veterans
- Males or females
- Aged 55 or older
- With a diagnosis of dementia (either Alzheimer's disease, vascular dementia, or mixed Alzheimer's and vascular dementia)
- Residing in a Tuscaloosa VA Medical Center (TVAMC) NHCU bed
Key exclusion criteria (15 listed)
- Diagnosis of dementia caused by a condition other than either Alzheimer's disease, vascular dementia, or mixed Alzheimer's and vascular dementia
- History of schizophrenia, bipolar disorder, or schizoaffective disorder
- Untreated depressive or anxiety disorder
- Untreated pain evident on physical examination
- Known allergy or hypersensitivity to either study drug
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 ERAlso: Divalproexdepakote ER | Drug | Depakote ER |
| SeroquelAlso: quetiapineseroquel | Drug | Seroquel |
Primary outcome
Cohen-Mansfield Agitation Inventory (CMAI)
Time frame: 12 week
Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item scale to systematically assess agitation (higher is more severe).
1 secondary outcome
Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD)
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Investigator closed study and left VAMC.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Background: PubMed 10783434Shuster JL Jr. Palliative care for advanced dementia. Clin Geriatr Med. 2000 May;16(2):373-86. doi: 10.1016/s0749-0690(05)70062-8.
- Individual participant dataSharing planned: No
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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.
John L Shuster, MD principal investigator
Tuscaloosa Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Depakote ER and Seroquel in people with Agitation and Dementia, run by Tuscaloosa Research & Education Advancement Corporation 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 11 inclusion and 15 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: stopped early, as of the sponsor's last update on 27 Apr 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Investigator closed study and left VAMC.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohen-Mansfield Agitation Inventory (CMAI) (time frame: 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00315900, which also lists 1 linked publication.
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 27 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.