Compare Tolerability of an Overnight Switch to Gradual Switch Between Two Different Forms of Depakote

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by Veterans Affairs Medical Center, Miami.
Recruitment status was  Recruiting
Information provided by:
Veterans Affairs Medical Center, Miami Identifier:
First received: April 6, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted

The hypothesis is that the characteristics of extended release Depakote will allow overnight conversion of immediate release to extended release form of Depakote. This has been tested successfully in younger patients but not in individuals over the age of 60. We will include individuals between 60 and 80 years old.

Condition Intervention Phase
Behavioral Disturbance
Procedure: Rapid versus slow conversion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conversion From Multiple-Daily Dose Enteric-Coated Depakote to Once-Daily Depakote ER in Elderly Outpatients With Epilepsy or Behavioral Disturbances:

Resource links provided by NLM:

Further study details as provided by Veterans Affairs Medical Center, Miami:

Primary Outcome Measures:
  • Between group comparisons of GI and CNS side effect burden

Secondary Outcome Measures:
  • Between group comparison of Quality of Life as measured bye the QOLIE-89
  • Between group comparison of trough Total and Free valproic acid serum levels

Estimated Enrollment: 20
Study Start Date: March 2006
Estimated Study Completion Date: October 2006
Detailed Description:

Twenty patients will be randomily assigned to convert overnight (10 pts) or over six days (10 pts). Side effects will be formally evaluated by the UKU side effect rating scal which will be done 7 days before conversion (day -7), the day of conversion (day 0)and then at the start of days +2, +7 and +14. This investigator conducting the evaluation will be blinded to the conversion status of the patient. Secondary measures to be obtained will be a Quality of Life measure (QOLIE-89) on Day 0 and +14. Plasma samples will be obtained on Day 0 and +14 before dosing for total and free valproic blood level.


Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 60 yo and older on stable dose of valproate (Depakote DR)

Exclusion Criteria:

  • Unstable neurolgical, medical or psychiatric disorder
  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 identifier: NCT00312676

Contact: Renato Seguro, MD 305-575-7000 ext 6033
Contact: Trichia Ramsay 305-575-7000 ext 3963

United States, Florida
Miami VA Medical Center Recruiting
Miami, Florida, United States, 33125
Contact: R. Eugene Ramsay, MD    305-575-3192   
Principal Investigator: R. Eugene Ramsay, MD         
Sponsors and Collaborators
Veterans Affairs Medical Center, Miami
Principal Investigator: R. Eugene Ramsay, MD Miami Veterans Administration Medical Center
  More Information

No publications provided Identifier: NCT00312676     History of Changes
Other Study ID Numbers: 7332.55b
Study First Received: April 6, 2006
Last Updated: April 6, 2006
Health Authority: United States: Federal Government

Keywords provided by Veterans Affairs Medical Center, Miami:
Depakote DR
Depakote ER

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Valproic Acid
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on October 23, 2014