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:

MedlinePlus related topics: Personality Disorders

Drug Information available for: Valproic acid Valproate sodium Divalproex sodium

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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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.


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:


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

ClinicalTrials.gov processed this record on September 26, 2016

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