Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2010 by University of Chicago
Sponsor:
Collaborators:
Temple University
Northwestern University
University of Southern Mississippi
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT01103180
First received: April 12, 2010
Last updated: December 20, 2010
Last verified: December 2010
  Purpose

The goal of this study is to examine the effectiveness the selective serotonin reuptake inhibitor (SSRI) escitalopram (also known by the trade name "Lexapro") in reducing desire to self-harm and actual self-harming among young adults with borderline personality disorder who are also currently depressed. Subjects will receive either escitalopram or placebo for eight weeks. During this time subjects will be make weekly visits to see the psychiatrist and record their thoughts and feelings several times each day using an electronic diary.


Condition Intervention Phase
Borderline Personality Disorder
Drug: Escitalopram
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SSRIs and Self-harm in Borderline Personality Disorder

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • self-harm ideation [ Time Frame: pretreatment to 1-week post treatment ] [ Designated as safety issue: Yes ]
    Self-harm ideation will be assessed using electronic diaries throught the trial from one week pre-treatment to one week post-treatment


Secondary Outcome Measures:
  • Depressive symptoms [ Time Frame: pre-treatment to 1 week post-treatment ] [ Designated as safety issue: No ]
    depressive symptoms will be assessed using weekly interviews and electronic diaries throught the trial from one week pre-treatment to one week post-treatment


Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Escitalopram
10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
Drug: Escitalopram
10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
Other Name: Lexapro
Placebo Comparator: Placebo
Inert placebo (sugar pill) taken daily for eight weeks
Drug: Escitalopram
10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
Other Name: Lexapro

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Borderline Personality Disorder
  • Current Major Depression

Exclusion Criteria:

  • Past 2 months SSRI use
  • Past 6 months non-SSRI antidepressant use
  • Past 2 months initiation of psychotherapy
  • Lifetime bipolar disorder, organic disorder, psychotic disorder
  • Current alcohol or drug dependence
  • Current severe suicidal / homicidal ideation necessitating immediate medical intervention
  • Currently pregnancy or nursing
  • Unable or unwilling to cooperate with study protocol
  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: NCT01103180

Contacts
Contact: Emil F Coccaro, M.D. 773 834-4083 ecoccaro@yoda.bsd.uchicago.edu

Locations
United States, Illinois
The University of Chicago Hospitals Recruiting
Chicago, Illinois, United States, 60637
Contact: Emil F Coccaro, M.D.    773-834-4083    ecoccaro@yoda.bsd.uchicago.edu   
Principal Investigator: Emil F Coccaro, M.D.         
Sponsors and Collaborators
University of Chicago
Temple University
Northwestern University
University of Southern Mississippi
Investigators
Principal Investigator: Michael S McCloskey, Ph.D Temple University (primary) / University of Chicago
Principal Investigator: Emil F Coccaro, M.D. University of Chicago
  More Information

No publications provided

Responsible Party: Emil F. Coccaro M.D. / Chair of Psychiatry and Michael S McCloskey, Ph.D. / Assistant Professor, The University of Chicago and Temple University
ClinicalTrials.gov Identifier: NCT01103180     History of Changes
Other Study ID Numbers: MH084904
Study First Received: April 12, 2010
Last Updated: December 20, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Selective Serotonin Reuptake Inhibitor
Escitalopram
Borderline Personality Disorder
Major Depressive Disorder
Self-harm

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders
Dexetimide
Citalopram
Serotonin Uptake Inhibitors
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on July 20, 2014