Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder

Phase 2

Terminated

• Conditions: Borderline Personality Disorder
• Interventions: Drug: Escitalopram

• Registration Number: NCT01103180
• Lead Sponsor: University of Chicago

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 available

Study Timeline

• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-14
• Study Start: 2010-09
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2017-07-24
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-12
• Last Update Submitted: 2019-06-12
• Results First Posted: 2019-06-14
• Last Update Posted: 2019-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Escitalopram	Escitalopram	10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
Placebo	Escitalopram	Inert placebo (sugar pill) taken daily for eight weeks

Primary Outcome Measures

Name	Time	Method
Self-harm Ideation	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.

Secondary Outcome Measures

Name	Time	Method
Depressive Symptoms	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)

Trial Locations

Locations (1)

The University of Chicago Hospitals; 🇺🇸 Chicago, Illinois, United States