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...
Date First Received: September 14, 2005
Last Updated: August 8, 2007
Verified by: University of Minnesota, August 2007
Clinical Trial Phase: N/A | Start Date: March 2003
Overall Status: Completed
Estimated Enrollment: 15
Brief Summary
Official Title: “A Double-Blind and Placebo Controlled Assessment of Depakote ER in Borderline Personality Disorder”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Depakote ER
Outcome Measures for this Clinical Trial
Primary Measures
- Symptom Checklist 90
Secondary Measures
- Barratt Impulsivity Scale
Criteria for Participation in this Clinical Trial
- 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. -
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 21 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Minnesota
Overall Clinical Trial Officials and Contacts
Sellamnn C Schulz, M.D. Principal Investigator Department of Psychiatry, University of Minnesota Medical School
Related Publications
References
Schulz SC, Camlin KL, Berry SA, Jesberger JA. Olanzapine safety and efficacy in patients with borderline personality disorder and comorbid dysthymia. Biol Psychiatry. 1999 Nov 15;46(10):1429-35.
Additional Information
Information obtained from ClinicalTrials.gov on October 07, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00222482
Study ID Number: 0306M49703
ClinicalTrials.gov Identifier: NCT00222482
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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