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Depakote ER in Borderline Personality Disorder

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Depakote ER
Sponsored by
University of Minnesota
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Borderline Personality Disorder

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Symptom Checklist 90

    Secondary Outcome Measures

    Barratt Impulsivity Scale

    Full Information

    First Posted
    September 14, 2005
    Last Updated
    August 8, 2007
    Sponsor
    University of Minnesota
    Collaborators
    Abbott, Schulz, S. Charles, M.D.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00222482
    Brief Title
    Depakote ER in Borderline Personality Disorder
    Official Title
    A Double-Blind and Placebo Controlled Assessment of Depakote ER in Borderline Personality Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Minnesota
    Collaborators
    Abbott, Schulz, S. Charles, M.D.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Borderline Personality Disorder
    Keywords
    Borderline Personality Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    15 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Depakote ER
    Primary Outcome Measure Information:
    Title
    Symptom Checklist 90
    Secondary Outcome Measure Information:
    Title
    Barratt Impulsivity Scale

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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. -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sellamnn C Schulz, M.D.
    Organizational Affiliation
    Department of Psychiatry, University of Minnesota Medical School
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10578457
    Citation
    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. doi: 10.1016/s0006-3223(99)00128-6.
    Results Reference
    background
    PubMed Identifier
    36375174
    Citation
    Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
    Results Reference
    derived

    Learn more about this trial

    Depakote ER in Borderline Personality Disorder

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