Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Depakote ER in Borderline Personality Disorder

This study has been completed.
Schulz, S. Charles, M.D.
Information provided by:
University of Minnesota - Clinical and Translational Science Institute Identifier:
First received: September 14, 2005
Last updated: August 8, 2007
Last verified: August 2007

This study examines the effect of Depakote ER versus placebo in a randomized trial of borderline personality disorder. Patients all participate in DBT therapy and those who are not responsive are assigned to either Depakote ER or placebo for up to 12 weeks. Borderline Personality Symtoms are measured and side-effects are assessed.

Condition Intervention
Borderline Personality Disorder
Drug: Depakote ER

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind and Placebo Controlled Assessment of Depakote ER in Borderline Personality Disorder

Resource links provided by NLM:

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Symptom Checklist 90

Secondary Outcome Measures:
  • Barratt Impulsivity Scale

Estimated Enrollment: 15
Study Start Date: March 2003
Study Completion Date: September 2005

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:Male or female patients with the diagnosis of borderline personality disorder between the ages of 21 adn 55 years old. Must be in good physical health -

Exclusion Criteria:Major psychiatric illness on Axis I - schizophrenia or bipolar disorder. May not have current MDD. May not be dependent on illicit substances or alcohol.


  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: NCT00222482

Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Schulz, S. Charles, M.D.
Principal Investigator: Sellamnn C Schulz, M.D. Department of Psychiatry, University of Minnesota Medical School
  More Information

Publications: Identifier: NCT00222482     History of Changes
Other Study ID Numbers: 0306M49703, M009946
Study First Received: September 14, 2005
Last Updated: August 8, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Borderline Personality Disorder

Additional relevant MeSH terms:
Borderline Personality Disorder
Personality Disorders
Mental Disorders
Pathologic Processes
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 November 25, 2014