Event Related Potentials in Borderline Personality Disord... | NCT01469663

Studies
Event Related Potentials in Borderline Personality Disorder and Major Depression

NCT01469663

Sponsor

State University of New York - Upstate Medical University

Status

Terminated

Last Update Posted

May 18, 2021Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Borderline Personality Disorder
Major Depression

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

software problem

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Oct 26, 2010

First Submission Date that Met QC Criteria

Nov 9, 2011

First Posted Date

Nov 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2021

Last Update Posted Date

May 18, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amruther G Ramamurthy, Assistant Professor, Dept of Psychiatry, State University of New York - Upstate Medical UniversityPrincipal Investigator

Lead Sponsor

State University of New York - Upstate Medical UniversityOTHER

Collaborators

Name	Class
Syracuse University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amruthur Ramamurthy, MD	State University of New York - Upstate Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Syracuse University - CNY Medical Center		Syracuse	New York	13078	United States
Upstate Medical University

IPD Sharing Statement Module

Plan to Share IPD

Description

There is no useful data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001883	Borderline Personality Disorder
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D010554	Personality Disorders
D001523	Mental Disorders
D003866	Depressive Disorder
D019964	Mood Disorders

Browse Leaves

Not provided

Browse Branches

Not provided