Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder

Study Overview
=================
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.

Official Title
-----------------
SSRIs and Self-harm in Borderline Personality Disorder

Conditions
-----------------
Borderline Personality Disorder

Intervention / Treatment
-----------------
* Drug: Escitalopram


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram<br>10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter) | Drug: Escitalopram<br>* 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)<br>* Other names: Lexapro;|
| Placebo Comparator: Placebo<br>Inert placebo (sugar pill) taken daily for eight weeks | Drug: Escitalopram<br>* 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)<br>* Other names: Lexapro;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Selective Serotonin Reuptake Inhibitor, Escitalopram, Borderline Personality Disorder, Major Depressive Disorder, Self-harm