Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder

NCT ID: NCT01103180

Last Updated: 2019-06-14

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Borderline Personality Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Escitalopram

10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)

Placebo

Inert placebo (sugar pill) taken daily for eight weeks

Group Type PLACEBO_COMPARATOR

Escitalopram

Intervention Type DRUG

10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)

Interventions

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Escitalopram

10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)

Intervention Type DRUG

Other Intervention Names

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Lexapro

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Temple University

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role collaborator

University of Southern Mississippi

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael S McCloskey, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Temple University (primary) / University of Chicago

Emil F Coccaro, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago Hospitals

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36375174 (View on PubMed)

Other Identifiers

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MH084904

Identifier Type: -

Identifier Source: org_study_id

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