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Trial record 93 of 610 for:    Personality Disorders

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

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ClinicalTrials.gov Identifier: NCT00834834
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : August 18, 2017
Last Update Posted : August 18, 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: Single (Investigator);   Primary Purpose: Treatment
Conditions Borderline Personality Disorder
Suicide
Interventions Drug: Fluoxetine
Behavioral: DBT
Drug: Citalopram
Enrollment 84
Recruitment Details Recruitment is from community clinicians, advertising and the emergency department.
Pre-assignment Details All participants are washed out of psychotropic medications. Benzodiazapines are permitted for sleep.
Arm/Group Title Fluoxetine Dialectical Behavior Therapy
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 42 42
Completed 38 39
Not Completed 4 3
Reason Not Completed
Withdrawal by Subject             4             3
Arm/Group Title Fluoxetine Dialectical Behavior Therapy Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 42 42 84
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 42 participants 84 participants
27.9  (7.8) 30.6  (10.8) 29.3  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
Female
37
  88.1%
40
  95.2%
77
  91.7%
Male
5
  11.9%
2
   4.8%
7
   8.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
Hispanic or Latino
9
  21.4%
11
  26.2%
20
  23.8%
Not Hispanic or Latino
33
  78.6%
31
  73.8%
64
  76.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Suicide Events
Hide Description 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.
Time Frame Measured after 6 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoxetine Dialectical Behavior Therapy
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: suicide events
12 4
2.Secondary Outcome
Title Number of Participants With Suicide Events
Hide Description 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.
Time Frame measured after 6 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluoxetine Dialectical Behavior Therapy
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 38 39
Measure Type: Number
Unit of Measure: participants
6 4
Time Frame During 6 month treatment trial and 1 year follow up period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluoxetine Dialectical Behavior Therapy
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Fluoxetine Dialectical Behavior Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluoxetine Dialectical Behavior Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/38 (36.84%)      5/39 (12.82%)    
Psychiatric disorders     
Serious Adverse Event  [1]  14/38 (36.84%)  15 5/39 (12.82%)  8
Indicates events were collected by systematic assessment
[1]
Includes suicidal behavior and psychiatric hospitalization Adverse Events were monitored/assessed without regard to the specific event and labeled as "Serious Adverse Event"
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fluoxetine Dialectical Behavior Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      0/39 (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, Ph.D.
Organization: NYSPI
Phone: 6467747582
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00834834     History of Changes
Other Study ID Numbers: #5752/6777R
R01MH061017 ( U.S. NIH Grant/Contract )
R01MH061017-06A2 ( U.S. NIH Grant/Contract )
First Submitted: February 2, 2009
First Posted: February 3, 2009
Results First Submitted: October 6, 2016
Results First Posted: August 18, 2017
Last Update Posted: August 18, 2017