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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00834834
First received: February 2, 2009
Last updated: July 20, 2017
Last verified: July 2017
Results First Received: October 6, 2016  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment is from community clinicians, advertising and the emergency department.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants are washed out of psychotropic medications. Benzodiazapines are permitted for sleep.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Fluoxetine   Dialectical Behavior Therapy
STARTED   42   42 
COMPLETED   38   39 
NOT COMPLETED   4   3 
Withdrawal by Subject                4                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Fluoxetine   Dialectical Behavior Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   42   84 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.9  (7.8)   30.6  (10.8)   29.3  (9.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      37  88.1%      40  95.2%      77  91.7% 
Male      5  11.9%      2   4.8%      7   8.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Suicide Events   [ Time Frame: Measured after 6 months of treatment ]

2.  Secondary:   Number of Participants With Suicide Events   [ Time Frame: measured after 6 months of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: stanley@nyspi.columbia.edu



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 )
Study First Received: February 2, 2009
Results First Received: October 6, 2016
Last Updated: July 20, 2017