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| Tracking Information | |||||||||
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| First Received Date ICMJE | July 31, 2006 | ||||||||
| Last Updated Date | July 31, 2006 | ||||||||
| Start Date ICMJE | July 2006 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
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| 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 | Guanfacine to Treat Borderline Personality Disorder | ||||||||
| Official Title ICMJE | Guanfacine in the Treatment of Borderline Personality Disorder | ||||||||
| Brief Summary | This study is designed to investigate whether guanfacine (Tenex) is an effective treatment for borderline personality disorder (BPD), an illness often characterized by unstable mood and impulsive aggression. Guanfacine stimulates activity in the front portion of the brain, a region associated with attention and the control of behavior. We believe that guanfacine may improve symptoms of BPD by improving attention and aiding regulation of behavior. |
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| Detailed Description | This is an 8-week treatment study designed to test whether guanfacine is an effective treatment for borderline personality disorder (BPD). Prior to taking the study medication, subjects will have medical and psychiatric evaluations, complete self-report questionnaires, do a functional MRI scan, and complete a set of cognitive tests. While taking the study medication, participants will meet weekly with a study doctor and be administered interviews and questionnaires. At the end of the 8-week trial, participants will be asked to repeat the MRI scan and cognitive tests. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Non-Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Borderline Personality Disorder | ||||||||
| Intervention ICMJE | Drug: guanfacine (Tenex) | ||||||||
| 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: This study includes men and women between the ages of 18 and 55 who meet criteria for borderline personality disorder with impulsive aggression. Exclusion Criteria: Subjects must not currently be taking any psychiatric medications. Subjects must not meet criteria for current substance dependence, current major depression, bipolar disorder, or schizophrenia-spectrum disorders. |
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| Gender | Both | ||||||||
| Ages | 18 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00358969 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | GCO 06-0518 | ||||||||
| Study Sponsor ICMJE | Mount Sinai School of Medicine | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Bronx VA Medical Center | ||||||||
| Verification Date | July 2006 | ||||||||
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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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