Back to resultsSelective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder
Primary Purpose
Borderline Personality Disorder
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
About this trial
This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Selective Serotonin Reuptake Inhibitor, Escitalopram, Borderline Personality Disorder, Major Depressive Disorder, Self-harm
Eligibility 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
Sites / Locations
- The University of Chicago Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Escitalopram
Placebo
Arm Description
10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
Inert placebo (sugar pill) taken daily for eight weeks
Outcomes
Primary Outcome Measures
Self-harm Ideation
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.
Secondary Outcome Measures
Depressive Symptoms
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)
Full Information
NCT ID
NCT01103180
First Posted
April 12, 2010
Last Updated
June 12, 2019
Sponsor
University of Chicago
Collaborators
Temple University, Northwestern University, University of Southern Mississippi
1. Study Identification
Unique Protocol Identification Number
NCT01103180
Brief Title
Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder
Official Title
SSRIs and Self-harm in Borderline Personality Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Funding withdrawn due to inability to accrue
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Temple University, Northwestern University, University of Southern Mississippi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
Selective Serotonin Reuptake Inhibitor, Escitalopram, Borderline Personality Disorder, Major Depressive Disorder, Self-harm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inert placebo (sugar pill) taken daily for eight weeks
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
Primary Outcome Measure Information:
Title
Self-harm Ideation
Description
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.
Time Frame
pre-treatment (week 0) to post-treatment (end of week 8)
Secondary Outcome Measure Information:
Title
Depressive Symptoms
Description
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)
Time Frame
baseline (week 0) and post treatment (week 8).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S McCloskey, Ph.D
Organizational Affiliation
Temple University (primary) / University of Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emil F Coccaro, M.D.
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago Hospitals
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36375174
Citation
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.
Results Reference
derived
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Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder
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