NCT00222482

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2003

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

August 9, 2007

Status Verified

August 1, 2007

First QC Date

September 14, 2005

Last Update Submit

August 8, 2007

Conditions

Borderline Personality Disorder

Keywords

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

  • Symptom Checklist 90

Secondary Outcomes (1)

  • Barratt Impulsivity Scale

Interventions

Depakote ERDRUG

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 10578457BACKGROUND

  • 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.

    PMID: 36375174DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Sellamnn C Schulz, M.D.

    Department of Psychiatry, University of Minnesota Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

March 1, 2003

Study Completion

September 1, 2005

Last Updated

August 9, 2007

Record last verified: 2007-08