Trial Outcomes & Findings for Treating Suicidal Behavior and Self-Mutilation in People With Borderline Personality Disorder (NCT NCT00533117)
NCT ID: NCT00533117
Last Updated: 2024-01-05
Results Overview
Suicide attempt count total over the course of the 12 month treatment period (sum of 6 bimonthly assessments during the treatment phase)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
91 participants
Primary outcome timeframe
Assessed bimonthly
Results posted on
2024-01-05
Participant Flow
Participants were recruited from the emergency department, clinician referrals and advertisements. Recruitment period ended 6 months prior to study end date.
91 participants signed consent, 86 were randomized, 11 participants dropped out prior to treatment start. Therefore 75 participants remained, accounting for the discrepancy between the original 91 participants and the final count of 75. Participants were washed out of all psychotropic medications. Benzodiazepine is permitted for sleep.
Participant milestones
| Measure |
DBT Fluoxetine
Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period,and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.
Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated
Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group.
|
DBT Placebo
Dialectal behavior therapy and placebo Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period, and placebo for fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.
Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group.
|
Supportive Therapy Fluoxetine
Supportive psychotherapy and fluoxetine Supportive therapy is a manualized psychotherapy aimed at strengthening coping skills and is delivered over a 12 month period, and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.
Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated
Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress.
|
Supportive Therapy Placebo
Supportive psychotherapy and placebo See above for descriptions.
Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
20
|
18
|
|
Overall Study
COMPLETED
|
14
|
14
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treating Suicidal Behavior and Self-Mutilation in People With Borderline Personality Disorder
Baseline characteristics by cohort
| Measure |
Dialectical Behavior Therapy Fluoxetine
n=18 Participants
Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period,and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.
Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated
Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group.
|
Dialectical Behavior Therapy Placebo
n=19 Participants
Dialectal behavior therapy and placebo Dialectal behavior therapy (DBT) is a form of Cognitive behavior therapy targeting suicidal and non-suicidal self injury in borderline personality disorder and is delivered over a 12 month period, and placebo for fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.
Dialectical Behavior Therapy: Dialectical Behavior Therapy is a form of CBT originally developed to treat suicidal and self injuring individuals with borderline personality disorder. Treatment consists of 2 sessions/week: individual psychotherapy and skills training group.
|
Supportive Therapy Fluoxetine
n=20 Participants
Supportive psychotherapy and fluoxetine Supportive therapy is a manualized psychotherapy aimed at strengthening coping skills and is delivered over a 12 month period, and fluoxetine, an SSRI that is given in standard dosing 20, 40, 60, 80 mg for 12 months.
Fluoxetine: Fluoxetine is administered in standard dosing 20, 40, 60, 80 mg increased monthly if tolerated
Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress.
|
Supportive Therapy Placebo
n=18 Participants
Supportive psychotherapy and placebo See above for descriptions.
Supportive psychotherapy: Supportive therapy is a manualized form of psychotherapy designed to enhance individual's strengths and coping mechanisms while reducing distress.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
28.6 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
29.1 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
32.3 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
31.8 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
30.2 years
STANDARD_DEVIATION 8.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Assessed bimonthlyPopulation: Suicidal and/or self injuring individuals with borderline personality disorder.
Suicide attempt count total over the course of the 12 month treatment period (sum of 6 bimonthly assessments during the treatment phase)
Outcome measures
| Measure |
Dialectical Behavior Therapy With Fluoxetine
n=18 Participants
Participants received 12 months of DBT and Fluoxetine medication with weekly medication visits (medication condition double blind)
|
Dialectical Behavior Therapy With Placebo
n=19 Participants
Participants received 12 months of DBT and placebo with weekly medication visits (medication condition double blind)
|
Supportive Therapy With Fluoxetine
n=20 Participants
Participants received 12 months of ST with fluoxetine medication with weekly medication visits (medication condition double blind)
|
Supportive Therapy With Placebo
n=18 Participants
Participants received 12 months of ST placebo medication with weekly medication visits (medication condition double blind)
|
|---|---|---|---|---|
|
Suicide Attempts
|
2 suicide attempt
|
1 suicide attempt
|
4 suicide attempt
|
1 suicide attempt
|
Adverse Events
Dialectical Behavior Therapy With Fluoxetine
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Supportive Therapy With Fluoxetine
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Dialectical Behavior Therapy With Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Supportive Therapy With Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dialectical Behavior Therapy With Fluoxetine
n=18 participants at risk
Participants received 12 months of DBT therapy with fluoxetine with weekly medication management sessions (double blind). Primary planned analyses were with supportive therapy/placebo. Also, the fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups. Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo, to test the hypothesis regarding differences in the primary outcome measure between the two medication groups.
|
Supportive Therapy With Fluoxetine
n=20 participants at risk
Participants received 12 months of supportive therapy with fluoxetine weekly medication management sessions(double blind). Planned analyses were with supportive therapy/placebo. Also, fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups. Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo. to test the hypothesis regarding differences in the primary outcome measure between the two medication groups..
|
Dialectical Behavior Therapy With Placebo
n=19 participants at risk
Participants received 12 months of DBT therapy with placebo medication with weekly medication management sessions (double blind). Also, the fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups.Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo, to test the hypothesis regarding differences in the primary outcome measure between the two medication groups.
|
Supportive Therapy With Placebo
n=18 participants at risk
Participants received 12 months of supportive therapy with placebo weekly medication management sessions(double blind). This condition served as the control condition. Also, the fluoxetine and placebo medication arms were collapsed into one in order to test the hypothesis regarding differences in the primary outcome variable between the two psychotherapy groups.Similarly the psychotherapy conditions were collapsed to compare fluoxetine vs. placebo, to test the hypothesis regarding differences in the primary outcome measure between the two medication groups.
|
|---|---|---|---|---|
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Psychiatric disorders
Hospitalization or ED visitn
|
5.6%
1/18 • Number of events 1 • During study enrollment (12 months)
|
10.0%
2/20 • Number of events 2 • During study enrollment (12 months)
|
0.00%
0/19 • During study enrollment (12 months)
|
0.00%
0/18 • During study enrollment (12 months)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place