Event Related Potentials in Borderline Personality Disorder and Major Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by State University of New York - Upstate Medical University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Syracuse University
Information provided by (Responsible Party):
Amruther G Ramamurthy, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT01469663
First received: October 26, 2010
Last updated: November 9, 2011
Last verified: November 2011
  Purpose

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.


Condition
Borderline Personality Disorder
Major Depression

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Event Related Potentials in Borderline Personality Disorder and Major Depression

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • Error related negativity amplitude [ Time Frame: on day 1 and then 4 weeks (average) later ] [ Designated as safety issue: No ]
    electroencephalogram amplitude of the error related negativity

  • N2 amplitude [ Time Frame: on day 1 and then 4 weeks (average) later ] [ Designated as safety issue: No ]
    electroencephalogram amplitude of N2 wave


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469663

Contacts
Contact: Amruthur G Ramamurthy, MD 315 464 5668 ramamurg@upstate.edu
Contact: Robert Gregory, MD 315 464 3169 gregoryr@upstate.edu

Locations
United States, New York
Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Amruthur Ramamurthy, MD    315-464-5668    agramam@gmail.com   
Principal Investigator: Amruthur Ramamurthy, MD         
Sub-Investigator: Robert Gregory, MD         
Sub-Investigator: Dennis Bogin, PhD         
Sub-Investigator: Wendy Kates, PhD         
Sub-Investigator: Tarakad Ramachandran, PhD         
Sub-Investigator: Kelly Wallace         
Sub-Investigator: Petya Radoeva         
Sub-Investigator: Laura A Miller         
Sub-Investigator: Eric MacMaster, MD         
Syracuse University - CNY Medical Center Not yet recruiting
Syracuse, New York, United States, 13078
Contact: Ramamurthy       agramam@gmail.com   
Sub-Investigator: Stephanie Ortigue, PhD         
Sponsors and Collaborators
State University of New York - Upstate Medical University
Syracuse University
Investigators
Principal Investigator: Amruthur Ramamurthy, MD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: Amruther G Ramamurthy, Assistant Professor, Dept of Psychiatry, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT01469663     History of Changes
Other Study ID Numbers: 5910
Study First Received: October 26, 2010
Last Updated: November 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
Borderline Personality Disorder
Major Depression
Electroencephalogram
N2
Error Related Negativity
Emotional Processing
Levels of Emotional Awareness

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on April 17, 2014