Borderline Personality Disorder
Conditions
Keywords
Selective Serotonin Reuptake Inhibitor, Escitalopram, Borderline Personality Disorder, Major Depressive Disorder, Self-harm
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.
Interventions
DRUGEscitalopram
10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
Sponsors
Temple University
Northwestern University
University of Southern Mississippi
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Escitalopram 10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter) | 35 |
| Placebo Inert placebo (sugar pill) taken daily for eight weeks | 35 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 7 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 13 |
Baseline characteristics
| Characteristic | Escitalopram | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 30.4 years STANDARD_DEVIATION 9.9 | 27.3 years STANDARD_DEVIATION 8.8 | 28.9 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 26 Participants | 26 Participants | 52 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 |
Outcome results
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.
Time frame: pre-treatment (week 0) to post-treatment (end of week 8)
Population: Data was not collected because the study was terminated.
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)
Time frame: baseline (week 0) and post treatment (week 8).
Population: Data was not collected because the study was terminated.