Text Size

Depakote ER in Borderline Personality Disorder

This study has been completed.
Sponsor:
Collaborators:
Abbott
Schulz, S. Charles, M.D.
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00222482
First received: September 14, 2005
Last updated: August 8, 2007
Last verified: August 2007
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00222482

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

Publications:

ClinicalTrials.gov 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:
Personality Disorders
Borderline Personality Disorder
Mental Disorders
Valproic Acid
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 May 23, 2013