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NCT00222482 Clinical Trial

Depakote ER in Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:
A Double-Blind and Placebo Controlled Assessment of Depakote ER in Borderline Personality Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00222482
Other study ID # 0306M49703
Secondary ID M009946
Status Completed
Phase N/A
First received September 14, 2005
Last updated August 8, 2007
Start date March 2003
Est. completion date September 2005

Study information
Verified date August 2007
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 55 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Depakote ER

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute Abbott, Schulz, S. Charles, M.D.

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Symptom Checklist 90
Secondary Barratt Impulsivity Scale
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