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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01469663
Other study ID # 5910
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 2011
Est. completion date March 2015

Study information

Verified date May 2021
Source State University of New York - Upstate Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Locations

Country Name City State
United States Syracuse University - CNY Medical Center Syracuse New York
United States Upstate Medical University Syracuse New York

Sponsors (2)

Lead Sponsor Collaborator
State University of New York - Upstate Medical University Syracuse University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Error related negativity amplitude electroencephalogram amplitude of the error related negativity on day 1 and then 4 weeks (average) later
Primary N2 amplitude electroencephalogram amplitude of N2 wave on day 1 and then 4 weeks (average) later
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