Borderline Personality DisorderPhase 2NCT01103180
Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder
A Phase 2 study testing Escitalopram in people with Borderline Personality Disorder, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Nov 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Borderline Personality Disorder
- Current Major Depression
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Hospitals
Chicago, Illinois, 60637
About this study
Official title: SSRIs and Self-harm in Borderline Personality Disorder
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.
- Conditions
- Borderline Personality Disorder
- Being tested
- Escitalopram
- Keywords
- Selective Serotonin Reuptake Inhibitor, Escitalopram, Borderline Personality Disorder, Major Depressive Disorder, Self-harm
- Medical subject headings
- Borderline Personality Disorder, Depressive Disorder, Major, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Lexapro
10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Experimental | 10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter) Receives: Drug: Escitalopram |
| Placebo | Placebo comparator | Inert placebo (sugar pill) taken daily for eight weeks Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-treatment (week 0) to post-treatment (end of week 8)
Secondary outcomes (1)
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)
Measured: baseline (week 0) and post treatment (week 8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Funding withdrawn due to inability to accrue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, Northwestern University, University of Southern Mississippi
- Responsible party
- Sponsor
- Investigators
- Michael S McCloskey, Ph.D, Principal investigator, Temple University (primary) / University of ChicagoEmil F Coccaro, M.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103180
- Sponsor's protocol ID
- MH084904
- Status last verified
- Jun 2019
- First submitted
- 12 Apr 2010
- Last updated
- 14 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 36375174
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SSRIs and Self-harm in Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT01103180
- Acronym / sponsor ID
- MH084904
- Conditions
- Borderline Personality Disorder
- Keywords
- Selective Serotonin Reuptake Inhibitor, Escitalopram, Borderline Personality Disorder, Major Depressive Disorder, Self-harm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding withdrawn due to inability to accrue
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Temple University, Northwestern University, University of Southern Mississippi
- Study start
- Sep 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 14 Apr 2010 (estimated)
- Results
- Posted 14 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Experimental | Drug: Escitalopram10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter) |
| Placebo | Placebo comparator | Drug: EscitalopramInert placebo (sugar pill) taken daily for eight weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of Borderline Personality Disorder
- Current Major Depression
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramAlso: Lexapro10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter) | Drug | Escitalopram, Placebo |
Primary outcome
Self-harm Ideation
Time frame: 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.
1 secondary outcome
Depressive Symptoms
Time frame: baseline (week 0) and post treatment (week 8).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36375174Stoffers-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S McCloskey, Ph.D principal investigator
Temple University (primary) / University of Chicago
Emil F Coccaro, M.D. principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Escitalopram in people with Borderline Personality Disorder, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-harm Ideation (time frame: pre-treatment (week 0) to post-treatment (end of week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01103180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.