- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01469663
Event Related Potentials in Borderline Personality Disorder and Major Depression
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13210
- Upstate Medical University
-
Syracuse, New York, United States, 13078
- Syracuse University - CNY Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Error related negativity amplitude
Time Frame: on day 1 and then 4 weeks (average) later
|
electroencephalogram amplitude of the error related negativity
|
on day 1 and then 4 weeks (average) later
|
|
N2 amplitude
Time Frame: on day 1 and then 4 weeks (average) later
|
electroencephalogram amplitude of N2 wave
|
on day 1 and then 4 weeks (average) later
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Amruthur Ramamurthy, MD, State University of New York - Upstate Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5910 (Other Grant/Funding Number: NCI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depression
-
Johns Hopkins UniversityNot yet recruitingMajor Depression | Major Depression Moderate | Major Depression SevereUnited States
-
Technical University of MunichEnrolling by invitationMajor Depression Moderate | Major Depression SevereGermany
-
Stanford UniversityTerminatedMajor Depressive Disorder | Major Depressive Episode | Major Depressive Disorder, Recurrent | Major Depression Mild | Major Depression Moderate | Major Depression SevereUnited States
-
Hawler Medical UniversityCompleted
-
Centre Hospitalier Universitaire de BesanconH. Lundbeck A/SCompletedResistant Major DepressionFrance
-
Cybin IRL LimitedWorldwide Clinical TrialsRecruitingDepression | Major Depressive Disorder (MDD) | Depression - Major Depressive Disorder | Depression in Adults | Depression Disorders | Depression DisorderUnited States, Australia, United Kingdom, Germany, Greece, Poland, Ireland, Czechia
-
First Affiliated Hospital of Zhejiang UniversityCompleted
-
University of PittsburghCompletedPostpartum Major DepressionUnited States
-
Si TianmeiUnknownMajor Depression DisorderChina
-
The Hong Kong Polytechnic UniversityActive, not recruitingHealthy | Major Depression in RemissionChina