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Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01103180
Recruitment Status : Terminated (Funding withdrawn due to inability to accrue)
First Posted : April 14, 2010
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborators:
Temple University
Northwestern University
University of Southern Mississippi
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE April 12, 2010
First Posted Date  ICMJE April 14, 2010
Results First Submitted Date  ICMJE July 24, 2017
Results First Posted Date  ICMJE June 14, 2019
Last Update Posted Date June 14, 2019
Study Start Date  ICMJE September 2010
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
Self-harm Ideation [ Time Frame: pre-treatment (week 0) to post-treatment (end of week 8) ]
Self-harm ideation was measured by electronic diaries (EMA) up to four times a day. Each time a person completed an EMA diary they were asked to rate their urge to hurt themselves on a 5 point scale ( 0 to 4) pad where 0 is not at all, 2 is moderately and 4 is extremely strong.
Original Primary Outcome Measures  ICMJE
 (submitted: April 13, 2010)
Self-harm Ideation [ Time Frame: pretreatment to 1-week post treatment ]
Self-harm ideation will be assessed using electronic diaries throught the trial from one week pre-treatment to one week post-treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
Depressive Symptoms [ Time Frame: baseline (week 0) and post treatment (week 8). ]
Depressive symptoms was assessed via (a) electronic diary (i.e. sum of eight POMS-D items: sad, unhappy, blue, hopeless, discouraged, miserable, helpless and worthless rated using 0-4 scale above) and (b) weekly interview(Hamilton depression rating)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2010)
Depressive Symptoms [ Time Frame: pre-treatment to 1 week post-treatment ]
depressive symptoms will be assessed using weekly interviews and electronic diaries throught the trial from one week pre-treatment to one week post-treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder
Official Title  ICMJE SSRIs and Self-harm in Borderline Personality Disorder
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Borderline Personality Disorder
Intervention  ICMJE Drug: Escitalopram
10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
Other Name: Lexapro
Study Arms  ICMJE
  • Experimental: Escitalopram
    10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo
    Inert placebo (sugar pill) taken daily for eight weeks
    Intervention: Drug: Escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 12, 2019)
70
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2010)
200
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01103180
Other Study ID Numbers  ICMJE MH084904
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE
  • Temple University
  • Northwestern University
  • University of Southern Mississippi
Investigators  ICMJE
Principal Investigator: Michael S McCloskey, Ph.D Temple University (primary) / University of Chicago
Principal Investigator: Emil F Coccaro, M.D. University of Chicago
PRS Account University of Chicago
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP