Recruiting
Phase 1

Depakote

Sponsor:

Hearthstone Alzheimer Care

Code:

NCT00197834

Conditions

Dementia

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Depakote

Study Details

Brief 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 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.

Conditions

Dementia

Study ID

NCT00197834

Start date

Mar, 2004

Status verified date

Sep, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Depakote

Primary outcome measure

  • Change from baseline on CMAI sub-scales [ Time Frame: undefined ]
  • Blood levels of effective dose [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Joan Hyde, Ph.D.

781-674-2884hyde@thehearth.org

Locations

Hearthstone at Golden Pond

Recruiting

Hopkinton, Massachusetts, United States, 01748

Contacts

Mark Vanelli, MD

800-378-5454mvanelli@comcast.net

More Information

Sponsor

Hearthstone Alzheimer Care

Last update posted

Aug 15, 2006

Last verified

Sep, 2005

Keywords

  • Depakote
  • Agitation
  • Dementia
  • Atypical antipsychotic
  • Behavioral Symptoms
  • Psychiatric Symptoms
  • Psychological Symptoms
  • Geriatric
  • Behavioral and Psychological Symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hearthstone Alzheimer Care on 2006-08-15.