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Trial record 31 of 532 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Recruitment Status : Terminated (Funding withdrawn due to inability to accrue)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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Borderline Personality Disorder
Intervention Drug: Escitalopram
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description 10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter) Inert placebo (sugar pill) taken daily for eight weeks
Period Title: Overall Study
Started 35 35
Completed 13 14
Not Completed 22 21
Reason Not Completed
Withdrawal by Subject             8             13
Lost to Follow-up             13             7
Physician Decision             1             0
Protocol Violation             0             1
Arm/Group Title Escitalopram Placebo Total
Hide Arm/Group Description 10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter) Inert placebo (sugar pill) taken daily for eight weeks Total of all reporting groups
Overall Number of Baseline Participants 35 35 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 35 participants 70 participants
30.4  (9.9) 27.3  (8.8) 28.9  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
Female
26
  74.3%
26
  74.3%
52
  74.3%
Male
9
  25.7%
9
  25.7%
18
  25.7%
1.Primary Outcome
Title Self-harm Ideation
Hide Description 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.
Time Frame pre-treatment (week 0) to post-treatment (end of week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected because the study was terminated.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:

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)

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)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Depressive Symptoms
Hide Description 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)
Time Frame baseline (week 0) and post treatment (week 8).
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected because the study was terminated.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:

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)

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)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description

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)

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)

All-Cause Mortality
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/14 (0.00%) 
Early study termination due to recruitment difficulties leading to none of subjects analyzed
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Emil Coccaro
Organization: University of Chicago
Phone: 773-834-4083
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01103180     History of Changes
Other Study ID Numbers: MH084904
First Submitted: April 12, 2010
First Posted: April 14, 2010
Results First Submitted: July 24, 2017
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019