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Trial record 50 of 611 for:    Personality Disorders

Treating Suicidal Behavior and Self-Mutilation in People With Borderline Personality Disorder

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ClinicalTrials.gov Identifier: NCT00533117
Recruitment Status : Completed
First Posted : September 21, 2007
Results First Posted : August 28, 2017
Last Update Posted : August 28, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Borderline Personality Disorder
Interventions Drug: Fluoxetine
Behavioral: Dialectical Behavior Therapy
Behavioral: Supportive psychotherapy
Enrollment 91
Recruitment Details Participants were recruited from the emergency department, clinician referrals and advertisements. Recruitment period ended 6 months prior to study end date.
Pre-assignment Details 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.
Arm/Group Title DBT Fluoxetine DBT Placebo Supportive Therapy Fluoxetine Supportive Therapy Placebo
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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.

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 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 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.

Period Title: Overall Study
Started 18 19 20 18
Completed 14 14 14 13
Not Completed 4 5 6 5
Arm/Group Title Dialectical Behavior Therapy Fluoxetine Dialectical Behavior Therapy Placebo Supportive Therapy Fluoxetine Supportive Therapy Placebo Total
Hide Arm/Group Description

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.

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 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 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 of all reporting groups
Overall Number of Baseline Participants 18 19 20 18 75
Hide Baseline Analysis Population Description
Suicidal and/or self injuring individuals with borderline personality disorder.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 19 participants 20 participants 18 participants 75 participants
28.6  (6.9) 29.1  (8.3) 32.3  (8.6) 31.8  (11.2) 30.2  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 20 participants 18 participants 75 participants
Female
15
  83.3%
13
  68.4%
17
  85.0%
13
  72.2%
58
  77.3%
Male
3
  16.7%
6
  31.6%
3
  15.0%
5
  27.8%
17
  22.7%
1.Primary Outcome
Title Suicide Attempts
Hide Description Suicide attempt count total over the course of the 12 month treatment period (sum of 6 bimonthly assessments during the treatment phase)
Time Frame Assessed bimonthly
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Hide Analysis Population Description
Data was *prespecified* to be collected for the "Dialectical Behavior Therapy With or Without Fluoxetine" and "Supportive Therapy With or Without Fluoxetine" Arm/Group combination, therefore the four original treatment conditions were collapsed into 2 study arms for analysis of the primary outcome measure
Arm/Group Title Dialectical Behavior Therapy With or Without Fluoxetine Supportive Therapy With or Without Fluoxetine
Hide Arm/Group Description:
Participants received 12 months of DBT and either Fluoxetine or placebo medication with weekly medication visits (double blind)
Participants received 12 months of ST and either Fluoxetine or placebo medication with weekly medication visits (double blind)
Overall Number of Participants Analyzed 37 38
Measure Type: Number
Unit of Measure: suicide attempt
3 6
Time Frame During study enrollment (12 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dialectical Behavior Therapy With Fluoxetine Supportive Therapy With Fluoxetine Dialectical Behavior Therapy With Placebo Supportive Therapy With Placebo
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
Dialectical Behavior Therapy With Fluoxetine Supportive Therapy With Fluoxetine Dialectical Behavior Therapy With Placebo Supportive Therapy With Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dialectical Behavior Therapy With Fluoxetine Supportive Therapy With Fluoxetine Dialectical Behavior Therapy With Placebo Supportive Therapy With Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/18 (5.56%)      2/20 (10.00%)      0/19 (0.00%)      0/18 (0.00%)    
Psychiatric disorders         
Hospitalization or ED visitn *  1/18 (5.56%)  1 2/20 (10.00%)  2 0/19 (0.00%)  0 0/18 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dialectical Behavior Therapy With Fluoxetine Supportive Therapy With Fluoxetine Dialectical Behavior Therapy With Placebo Supportive Therapy With Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/20 (0.00%)      0/19 (0.00%)      0/18 (0.00%)    
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: Barbara Stanley
Organization: NYSPI
Phone: 6467747582
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00533117     History of Changes
Other Study ID Numbers: #5401R
R01MH061017-02 ( U.S. NIH Grant/Contract )
First Submitted: September 19, 2007
First Posted: September 21, 2007
Results First Submitted: October 6, 2016
Results First Posted: August 28, 2017
Last Update Posted: August 28, 2017