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| Tracking Information | |||||
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| First Received Date ICMJE | November 17, 2005 | ||||
| Last Updated Date | November 17, 2005 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Measures of impulsivity, aggression, affective impulsivity, immediate and delayed memory, and cognitive processing at baseline, 6 months and 9 months | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | DBT and Escitalopram in Borderline Personality Disorder | ||||
| Official Title ICMJE | Effects of Dialectical Behavioral Therapy and Escitalopram on Impulsive Aggression, Affective Instability and Cognitive Processing in Borderline Personality Disorder | ||||
| Brief Summary | Subjects will receive six months of DBT, consisting of one 90-minute group and one 60-minute individual session per week as well as telephone availability of the individual therapist. Half the subjects will concurrently receive escitalopram while half will receive placebo, in a randomized double-blind design. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment | ||||
| Condition ICMJE | Borderline Personality Disorder | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Is a male or female between 18 and 60 who meets criteria for Borderline Personality Disorder and has been off psychotropic medications for at least 2 weeks (6 weeks for fluoxetine). - Exclusion Criteria: Meets criteria for Schizophrenia, Bipolar Disorder, Mental Retardation, current or recent Substance Dependence or a current Major Depressive Episode. Subjects also should not currently be in individual psychotherapy. (Case management and work therapy programs are allowed.) - |
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00255554 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 3277-03-0027 | ||||
| Study Sponsor ICMJE | Bronx VA Medical Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Bronx VA Medical Center | ||||
| Verification Date | November 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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