Study of Depakote for Behavioral and Psychological Symptoms in Dementia

NCT00197834 | Unknown Phase 1

• 1 other identifier: NEIRB05032
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Depakote DRUG

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hearthstone Alzheimer Care: lead
• Abbott: collaborator

Study Sites (1)

Hearthstone at Golden Pond

Hopkinton, Massachusetts, 01748, United States

RECRUITING

MeSH Terms

Conditions

Dementia; Psychomotor Agitation; Behavioral Symptoms; Behavior

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Mark Vanelli, MD

  Hearthstone Alzheimer Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan Hyde, Ph.D.

CONTACT

781-674-2884; hyde@thehearth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: March 1, 2004
• Last Updated: August 15, 2006

Record last verified: 2005-09

Locations

US (1)