TerminatedNot Applicable

Event Related Potentials in Borderline Personality Disorder and Major Depression

Stopped: software problem

United States30 participantsStarted 2011-07

Plain-language 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. 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * mental retardation * dementia * CNS disease * Post-Traumatic Stress Disorder in non-borderline personality disorder groups * Recreational drug or alcohol use in the past week.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Error related negativity amplitude

Timeframe: on day 1 and then 4 weeks (average) later

N2 amplitude

Timeframe: on day 1 and then 4 weeks (average) later

Trial details

NCT IDNCT01469663

SponsorState University of New York - Upstate Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-03

View on ClinicalTrials.gov More Borderline Personality Disorder trials