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Trial record 31 of 531 for:    ESCITALOPRAM AND Disorders

Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder

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ClinicalTrials.gov Identifier: NCT01103180
Recruitment Status : Terminated (Funding withdrawn due to inability to accrue)
First Posted : April 14, 2010
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborators:
Temple University
Northwestern University
University of Southern Mississippi
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Drug: Escitalopram Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SSRIs and Self-harm in Borderline Personality Disorder
Study Start Date : September 2010
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Escitalopram
10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
Drug: Escitalopram
10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
Other Name: Lexapro

Placebo Comparator: Placebo
Inert placebo (sugar pill) taken daily for eight weeks
Drug: Escitalopram
10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
Other Name: Lexapro




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Depressive Symptoms [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103180


Locations
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United States, Illinois
The University of Chicago Hospitals
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Temple University
Northwestern University
University of Southern Mississippi
Investigators
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Principal Investigator: Michael S McCloskey, Ph.D Temple University (primary) / University of Chicago
Principal Investigator: Emil F Coccaro, M.D. University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01103180     History of Changes
Other Study ID Numbers: MH084904
First Posted: April 14, 2010    Key Record Dates
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019
Last Verified: June 2019

Keywords provided by University of Chicago:
Selective Serotonin Reuptake Inhibitor
Escitalopram
Borderline Personality Disorder
Major Depressive Disorder
Self-harm

Additional relevant MeSH terms:
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Disease
Personality Disorders
Borderline Personality Disorder
Mental Disorders
Citalopram
Dexetimide
Pathologic Processes
Serotonin Uptake Inhibitors
Serotonin
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Serotonin Receptor Agonists