Trial Outcomes & Findings for Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder (NCT NCT01103180)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

70 participants

Primary outcome timeframe

pre-treatment (week 0) to post-treatment (end of week 8)

Results posted on

2019-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Escitalopram 10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)	Placebo Inert placebo (sugar pill) taken daily for eight weeks
Overall Study STARTED	35	35
Overall Study COMPLETED	13	14
Overall Study NOT COMPLETED	22	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Escitalopram 10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)	Placebo Inert placebo (sugar pill) taken daily for eight weeks
Overall Study Withdrawal by Subject	8	13
Overall Study Lost to Follow-up	13	7
Overall Study Physician Decision	1	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Escitalopram n=35 Participants 10-20 mg of escitalopram for eight weeks (10mg for the first 2 weeks, 20mg thereafter)	Placebo n=35 Participants Inert placebo (sugar pill) taken daily for eight weeks	Total n=70 Participants Total of all reporting groups
Age, Continuous	30.4 years STANDARD_DEVIATION 9.9 • n=5 Participants	27.3 years STANDARD_DEVIATION 8.8 • n=7 Participants	28.9 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: pre-treatment (week 0) to post-treatment (end of week 8)

Population: Data was not collected because the study was terminated.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Data was not collected because the study was terminated.

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)

Outcome measures

Outcome data not reported

Adverse Events

Escitalopram

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Emil Coccaro

University of Chicago

Phone: 773-834-4083

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place