Study of Depakote for Behavioral and Psychological Symptoms in Dementia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Hearthstone Alzheimer Care.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
Hearthstone Alzheimer Care
ClinicalTrials.gov Identifier:
NCT00197834
First received: September 12, 2005
Last updated: August 10, 2006
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
Dementia
Drug: Depakote
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hearthstone Alzheimer Care:

Primary Outcome Measures:
  • Change from baseline on CMAI sub-scales
  • Blood levels of effective dose

Secondary Outcome Measures:
  • Change from baseline on CGI and NPI
  • Dosing information on Concomitant psychotropic medications
  • Adverse effects and tolerability

Estimated Enrollment: 20
Study Start Date: March 2004
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197834

Contacts
Contact: Joan Hyde, Ph.D. 781-674-2884 ext 30 hyde@thehearth.org

Locations
United States, Massachusetts
Hearthstone at Golden Pond Recruiting
Hopkinton, Massachusetts, United States, 01748
Contact: Mark Vanelli, MD    800-378-5454 ext 0    mvanelli@comcast.net   
Sponsors and Collaborators
Hearthstone Alzheimer Care
Abbott
Investigators
Principal Investigator: Mark Vanelli, MD Hearthstone Alzheimer Care
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00197834     History of Changes
Other Study ID Numbers: NEIRB05032
Study First Received: September 12, 2005
Last Updated: August 10, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Hearthstone Alzheimer Care:
Depakote
Agitation
Dementia
Atypical antipsychotic
Behavioral Symptoms
Psychiatric Symptoms
Psychological Symptoms
Geriatric
Behavioral and Psychological Symptoms

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Valproic Acid
Antipsychotic Agents
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 19, 2014