Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder

NCT01103180 | Terminated Phase 2 Results DMC

• 1 other identifier: MH084904
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Keywords

Selective Serotonin Reuptake Inhibitor; Escitalopram; Borderline Personality Disorder; Major Depressive Disorder; Self-harm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Depressive Symptoms

  baseline (week 0) and post treatment (week 8).

Study Arms (2)

Escitalopram

EXPERIMENTAL

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

Drug: Escitalopram

Placebo

PLACEBO COMPARATOR

Inert placebo (sugar pill) taken daily for eight weeks

Drug: Escitalopram

Interventions

Escitalopram DRUG

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

Also known as: Lexapro

Escitalopram; Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of Borderline Personality Disorder
• Current Major Depression

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• Temple University: collaborator
• Northwestern University: collaborator
• University of Southern Mississippi: collaborator

Study Sites (1)

The University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• 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.

  PMID: 36375174 DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder; Depressive Disorder, Major; Self-Injurious Behavior

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Early study termination due to recruitment difficulties leading to none of subjects analyzed

Results Point of Contact

• Title: Dr. Emil Coccaro
• Organization: University of Chicago

ecoccaro@yoda.bsd.uchicago.edu

773-834-4083

Study Officials

• Michael S McCloskey, Ph.D

  Temple University (primary) / University of Chicago

  PRINCIPAL INVESTIGATOR

• Emil F Coccaro, M.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 14, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 14, 2019
• Results First Posted: June 14, 2019

Record last verified: 2019-06

Locations

US (1)