Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

Official title:

SSRIs and Self-harm in Borderline Personality Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01103180
• Other study ID #: MH084904
• Status: Terminated
• Phase: Phase 2
• Start date: September 2010
• Est. completion date: November 2014

Study information

• Verified date: June 2019
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Disease
• Personality Disorders

Intervention

Drug:
• Escitalopram
10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)

Locations

Country	Name	City	State
United States	The University of Chicago Hospitals	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
University of Chicago	Northwestern University, Temple University, University of Southern Mississippi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	pre-treatment (week 0) to post-treatment (end of week 8)
Secondary	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)	baseline (week 0) and post treatment (week 8).