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Depakote ER in Borderline Personality Disorder

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ClinicalTrials.gov Identifier: NCT00222482
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 9, 2007
Sponsor:
Collaborators:
Abbott
Schulz, S. Charles, M.D.
Information provided by:
University of Minnesota - Clinical and Translational Science Institute

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Drug: Depakote ER Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind and Placebo Controlled Assessment of Depakote ER in Borderline Personality Disorder
Study Start Date : March 2003
Actual Study Completion Date : September 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Symptom Checklist 90

Secondary Outcome Measures :
  1. Barratt Impulsivity Scale

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

ClinicalTrials.gov Identifier: NCT00222482     History of Changes
Other Study ID Numbers: 0306M49703
M009946
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: August 9, 2007
Last Verified: August 2007

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

Additional relevant MeSH terms:
Disease
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders
Valproic Acid
Anticonvulsants
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