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Funding withdrawn due to inability to accrue
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| Name | Class |
|---|---|
| Temple University | OTHER |
| Northwestern University | OTHER |
| University of Southern Mississippi | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escitalopram | Experimental | 10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter) |
|
| Placebo | Placebo Comparator | Inert placebo (sugar pill) taken daily for eight weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter) |
|
| 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) |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael S McCloskey, Ph.D | Temple University (primary) / University of Chicago | Principal Investigator |
| Emil F Coccaro, M.D. | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago Hospitals | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36375174 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Escitalopram | 10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter) |
| FG001 | Placebo | Inert placebo (sugar pill) taken daily for eight weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Escitalopram | 10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter) |
| BG001 | Placebo | Inert placebo (sugar pill) taken daily for eight weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data was not collected because the study was terminated. | Posted | pre-treatment (week 0) to post-treatment (end of week 8) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Escitalopram | 10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter) Escitalopram: 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter) |
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Early study termination due to recruitment difficulties leading to none of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emil Coccaro | University of Chicago | 773-834-4083 | ecoccaro@yoda.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| D003865 | Depressive Disorder, Major |
| D016728 | Self-Injurious Behavior |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Physician Decision |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Inert placebo (sugar pill) taken daily for eight weeks
Escitalopram: 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
|
| 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) | Data was not collected because the study was terminated. | Posted | baseline (week 0) and post treatment (week 8). |
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Placebo | Inert placebo (sugar pill) taken daily for eight weeks Escitalopram: 10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter) | 0 | 14 | 0 | 14 |
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| D001526 |
| Behavioral Symptoms |
| D001519 | Behavior |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |