Borderline Personality DisorderNCT01469663
Event Related Potentials in Borderline Personality Disorder and Major Depression
An observational study of Borderline Personality Disorder and Major Depression, run by State University of New York - Upstate Medical University at 2 sites in United States.
Trial summary
This study examines whether depression in people with borderline personality disorder is different than depression in people without borderline personality disorder. Unlike people who have depression alone (i.e. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder, Major Depression
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2011to Mar 2015
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Females between age 18 to 45 recruited from staff (healthy controls) or from Upstate Medical University primary care outpatients, psychiatry outpatients, psychiatry inpatients
Who may be able to join
- age between 18 and 45
- female
- noncontrols diagnosis: major depression \&/or borderline personality disorder
- Control participants should have neither major depression or borderline pers.
- meet Structured Controlled Interview for DSM - II cut off scores
- meet Beck Depression Inventory (BDI)cut off scores
- meet Borderline Evaluation of Severity Over Time(BEST) cut off scores.
Who cannot join
- based on having none of the below diagnoses from patient history, prior clinical records and based on MINI Plus International Neuropsychiatry Interview
- schizophrenia
- psychosis
- Attention Deficit Hyperactivity Disorder
- Obsessive Compulsive Disorder
- bipolar disorder
Show all 11Show fewer
- mental retardation
- dementia
- CNS disease
- Post-Traumatic Stress Disorder in non-borderline personality disorder groups
- Recreational drug or alcohol use in the past week.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Syracuse University - CNY Medical Center
Syracuse, New York, 13078
Upstate Medical University
Syracuse, New York, 13210
About this study
This study examines whether depression in people with borderline personality disorder is different than depression in people without borderline personality disorder.
Unlike people who have depression alone (i.e. without borderline personality disorder), people with borderline personality disorder have depressions that often do not improve with medications. This makes treating depression much more challenging in someone with borderline personality disorder than without borderline personality disorder.
Read more
Borderline personality disorderis associated with difficulty in understanding and communicating feelings. Impaired emotion processing may reflect dysfunction of an area of the brain, the anterior cingulate.
Depression is associated with changes in anterior cingulate activity. The investigators believe that when borderline personality disorder is present with depression, brain activity changes in the anterior cingulate will not be the same as in depressed patients without borderline personality disorder.
An electroencephalogram records brain electrical activity. In this study, the investigators will measure electroencephalogram indices reflecting anterior cingulate activity.
HYPOTHESIS: In this study, the investigators predict that when borderline personality is present with depression, electroencephalogram indices of anterior cingulate activity will be different from when depression is present alone (without borderline personality). This could help to explain why people with borderline personality have depressions that are harder to treat than depressions in people without borderline personality.
The investigators also predict that electroencephalogram indices of the anterior cingulate will reflect emotional processing ability, as measured by validated questionnaires.
- Conditions
- Borderline Personality Disorder, Major Depression
- Keywords
- Borderline Personality Disorder, Major Depression, Electroencephalogram, N2, Error Related Negativity, Emotional Processing, Levels of Emotional Awareness
- Medical subject headings
- Borderline Personality Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Healthy participants without borderline personality or depression | |
| Major Depression, No Borderline Personality Disorder | With major depression and no borderline personality | |
| Major Depression + Borderline Personality Disorder | With major depression and borderline personality disorder | |
| No Major Depression, Borderline Personality Disorder | With no major depression, but with borderline personality disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Error related negativity amplitude
electroencephalogram amplitude of the error related negativity
Measured: on day 1 and then 4 weeks (average) later
N2 amplitude
electroencephalogram amplitude of N2 wave
Measured: on day 1 and then 4 weeks (average) later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: software problem
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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Syracuse University
- Responsible party
- Principal investigator, Amruther G Ramamurthy, State University of New York - Upstate Medical University
- Investigators
- Amruthur Ramamurthy, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469663
- Sponsor's protocol ID
- 5910
- Status last verified
- May 2021
- First submitted
- 26 Oct 2010
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no useful data
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Event Related Potentials in Borderline Personality Disorder and Major Depression
- ClinicalTrials.gov ID
- NCT01469663
- Acronym / sponsor ID
- 5910
- Conditions
- Borderline Personality Disorder, Major Depression
- Keywords
- Borderline Personality Disorder, Major Depression, Electroencephalogram, N2, Error Related Negativity, Emotional Processing, Levels of Emotional Awareness
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: software problem
- Enrolment
- 30 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- Syracuse University
- Study start
- Jul 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 10 Nov 2011 (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 examines whether depression in people with borderline personality disorder is different than depression in people without borderline personality disorder.
Unlike people who have depression alone (i.e. without borderline personality disorder), people with borderline personality disorder have depressions that often do not improve with medications. This makes treating depression much more challenging in someone with borderline personality disorder than without borderline personality disorder.
Borderline personality disorderis associated with difficulty in understanding and communicating feelings. Impaired emotion processing may reflect dysfunction of an area of the brain, the anterior cingulate.
Depression is associated with changes in anterior cingulate activity. The investigators believe that when borderline personality disorder is present with depression, brain activity changes in the anterior cingulate will not be the same as in depressed patients without borderline personality disorder.
An electroencephalogram records brain electrical activity. In this study, the investigators will measure electroencephalogram indices reflecting anterior cingulate activity.
HYPOTHESIS: In this study, the investigators predict that when borderline personality is present with depression, electroencephalogram indices of anterior cingulate activity will be different from when depression is present alone (without borderline personality). This could help to explain why people with borderline personality have depressions that are harder to treat than depressions in people without borderline personality.
The investigators also predict that electroencephalogram indices of the anterior cingulate will reflect emotional processing ability, as measured by validated questionnaires.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | –Healthy participants without borderline personality or depression |
| Major Depression, No Borderline Personality Disorder | – | –With major depression and no borderline personality |
| Major Depression + Borderline Personality Disorder | – | –With major depression and borderline personality disorder |
| No Major Depression, Borderline Personality Disorder | – | –With no major depression, but with borderline personality disorder |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Females between age 18 to 45 recruited from staff (healthy controls) or from Upstate Medical University primary care outpatients, psychiatry outpatients, psychiatry inpatients
Key inclusion criteria (7 listed)
- age between 18 and 45
- female
- noncontrols diagnosis: major depression \&/or borderline personality disorder
- Control participants should have neither major depression or borderline pers.
- meet Structured Controlled Interview for DSM - II cut off scores
Key exclusion criteria (11 listed)
- based on having none of the below diagnoses from patient history, prior clinical records and based on MINI Plus International Neuropsychiatry Interview
- schizophrenia
- psychosis
- Attention Deficit Hyperactivity Disorder
- Obsessive Compulsive Disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Error related negativity amplitude
Time frame: on day 1 and then 4 weeks (average) later
electroencephalogram amplitude of the error related negativity
N2 amplitude
Time frame: on day 1 and then 4 weeks (average) later
electroencephalogram amplitude of N2 wave
Results and safety
The study was stopped early (reason given: software problem). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Individual participant dataSharing planned: No. There is no useful data
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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.
Amruthur Ramamurthy, MD principal investigator
State University of New York - Upstate Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Personality Disorder and Major Depression, run by State University of New York - Upstate Medical University at 2 sites 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?
The sponsor lists 7 inclusion and 11 exclusion criteria. 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: stopped early, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: software problem). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Error related negativity amplitude (time frame: on day 1 and then 4 weeks (average) later). The study lists 2 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 18 May 2021.