Trial Outcomes & Findings for Comparing Treatments for Self-Injury and Suicidal Behavior in People With Borderline Personality Disorder (NCT NCT00834834)

Results Overview

Data on suicidal behavior was collected with the Columbia Suicide History Interview (CSHI), a semi-structured interview developed by our group. It is used to elicit history of the individual's actual suicide attempts , as well as specific questions concerning the circumstances surrounding any suicidal behavior and its degree of medical lethality. In addition to obtaining measurements of actual suicide attempts, the CSHI also captures suicide-related behaviors such as aborted and interrupted suicide attempts. An actual suicide attempt is operationally defined by the CSHI as a self-injurious act performed with at least some intent to die.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

84 participants

Primary outcome timeframe

Measured after 6 months of treatment

Results posted on

2017-08-18

Participant Flow

Recruitment is from community clinicians, advertising and the emergency department.

All participants are washed out of psychotropic medications. Benzodiazapines are permitted for sleep.

Participant milestones

Participant milestones
Measure	Fluoxetine Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI. Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months. Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.	Dialectical Behavior Therapy Participants will receive dialectical behavioral therapy (DBT). DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.
Overall Study STARTED	42	42
Overall Study COMPLETED	38	39
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Fluoxetine Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI. Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months. Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.	Dialectical Behavior Therapy Participants will receive dialectical behavioral therapy (DBT). DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.
Overall Study Withdrawal by Subject	4	3

Baseline Characteristics

Comparing Treatments for Self-Injury and Suicidal Behavior in People With Borderline Personality Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluoxetine n=42 Participants Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI. Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months. Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.	Dialectical Behavior Therapy n=42 Participants Participants will receive dialectical behavioral therapy (DBT). DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.	Total n=84 Participants Total of all reporting groups
Age, Continuous	27.9 years STANDARD_DEVIATION 7.8 • n=5 Participants	30.6 years STANDARD_DEVIATION 10.8 • n=7 Participants	29.3 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	40 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured after 6 months of treatment

Data on suicidal behavior was collected with the Columbia Suicide History Interview (CSHI), a semi-structured interview developed by our group. It is used to elicit history of the individual's actual suicide attempts , as well as specific questions concerning the circumstances surrounding any suicidal behavior and its degree of medical lethality. In addition to obtaining measurements of actual suicide attempts, the CSHI also captures suicide-related behaviors such as aborted and interrupted suicide attempts. An actual suicide attempt is operationally defined by the CSHI as a self-injurious act performed with at least some intent to die.

Outcome measures

Outcome measures
Measure	Fluoxetine n=38 Participants Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI. Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months. Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.	Dialectical Behavior Therapy n=39 Participants Participants will receive dialectical behavioral therapy (DBT). DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.
Suicide Events	12 suicide events	4 suicide events

SECONDARY outcome

Timeframe: measured after 6 months of treatment

Data on suicidal behavior was collected with the Columbia Suicide History Interview (CSHI), a semi-structured interview developed by our group. It is used to elicit history of the individual's actual suicide attempts , as well as specific questions concerning the circumstances surrounding any suicidal behavior and its degree of medical lethality. In addition to obtaining measurements of actual suicide attempts, the CSHI also captures suicide-related behaviors such as aborted and interrupted suicide attempts. An actual suicide attempt is operationally defined by the CSHI as a self-injurious act performed with at least some intent to die.

Outcome measures

Outcome measures
Measure	Fluoxetine n=38 Participants Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI. Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months. Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.	Dialectical Behavior Therapy n=39 Participants Participants will receive dialectical behavioral therapy (DBT). DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.
Number of Participants With Suicide Events	6 participants	4 participants

Adverse Events

Fluoxetine

Serious events: 14 serious events

Other events: 0 other events

Deaths: 0 deaths

Dialectical Behavior Therapy

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fluoxetine n=38 participants at risk Participants will receive fluoxetine with clinical management, which may involve switching medication to citalopram, another SSRI. Fluoxetine: Starting dose of 20 mg daily will increase over 4 weeks, depending on tolerability, up to 40 mg daily. Treatment will last 6 months. Citalopram: Dose set by study psychiatrist, up to 60 mg daily. Treatment will last 6 months.	Dialectical Behavior Therapy n=39 participants at risk Participants will receive dialectical behavioral therapy (DBT). DBT: One 60-minute individual therapy session and one 90-minute group therapy session every week. Treatment will last 6 months.
Psychiatric disorders Serious Adverse Event	36.8% 14/38 • Number of events 15 • During 6 month treatment trial and 1 year follow up period.	12.8% 5/39 • Number of events 8 • During 6 month treatment trial and 1 year follow up period.

Other adverse events

Adverse event data not reported

Additional Information

Barbara Stanley, Ph.D.

NYSPI

Phone: 6467747582

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place