Borderline Personality DisorderNCT00358969
Guanfacine to Treat Borderline Personality Disorder
A study testing guanfacine (Tenex) in people with Borderline Personality Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- guanfacine (Tenex)
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital - Mood & Personality Research Group
New York, New York, 10029
About this study
Official title: Guanfacine in the Treatment of Borderline Personality Disorder
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.
Read the 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.
- Conditions
- Borderline Personality Disorder
- Being tested
- guanfacine (Tenex)
- Keywords
- borderline personality disorder, guanfacine, impulsivity, aggression, affective instability
- Medical subject headings
- Borderline Personality Disorder, Impulsive Behavior, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guanfacine (Tenex)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
measures of impulsive aggression
measures of affective disturbance
measures of social and occupational functioning
measures of overall clinical status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Investigators
- Antonia S. New, M.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358969
- Sponsor's protocol ID
- GCO 06-0518
- Status last verified
- Jul 2006
- First submitted
- 31 Jul 2006
- Last updated
- 1 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guanfacine in the Treatment of Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT00358969
- Acronym / sponsor ID
- GCO 06-0518
- Conditions
- Borderline Personality Disorder
- Keywords
- borderline personality disorder, guanfacine, impulsivity, aggression, affective instability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jul 2006
- First posted
- 1 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| guanfacine (Tenex) | Drug | – |
Primary outcome
measures of impulsive aggression
measures of affective disturbance
measures of social and occupational functioning
measures of overall clinical status
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonia S. New, M.D. principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guanfacine (Tenex) in people with Borderline Personality Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emily Hart ((212) 241-4459, mpgroup@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measures of impulsive aggression. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2006.