Brain Network Activation Analysis to Diagnose/Assess Treatment of Unipolar Major Depression and Bipolar I Depression (BNA-Mood)

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

John Zajecka, Rush University Medical Center

ClinicalTrials.gov Identifier:

NCT01683214

First received: September 7, 2012

Last updated: April 4, 2016

Last verified: April 2016

History of Changes

Purpose

The investigators are conducting this study to test the usefulness of a new type of analysis of electroencephalographic (EEG) recordings called brain network activation or BNA. BNA allows to identify patterns of activation in brain networks and to track their changes over time. The investigators want to examine the possible role of brain network activation (BNA) in the diagnosis of mood disorders and predicting improvement over time. The procedure conducted with patients diagnosed with a mood disorder will be compared to people who do not have a mood disorder.

Condition
Depression


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Potential Use of Brain Network Activation (BNA) Analysis Using Evoked Response Potentials to Diagnose Unipolar Major Depression and Bipolar I Depression and Assess Response to Treatment

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:

Correlation of changes in BNA with changes in mood symptoms [ Time Frame: Beginning of study to end of study ] [ Designated as safety issue: No ]
This is an observational study, so no other outcomes are measured


Estimated Enrollment:	250
Study Start Date:	August 2012
Estimated Study Completion Date:	March 2018
Estimated Primary Completion Date:	March 2017 (Final data collection date for primary outcome measure)

Detailed Description:

Novel approach to ascertain use of BNA strategy and technology for the use in confirming diagnosis and predicting effect of specific treatment(s)in the various stages of affective/mood disorders. The goal is to develop non-invasive technology to confirm diagnosis via biological outcomes, and to study the preliminary data of predicting response/non-response to specific interventions before clinical effects are shown.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

This study will only enroll subjects who are participating in another specified clinical trial.The inclusion/exclusion criteria will depend on the criteria for each of the studies utilizing subjects with depression or bipolar type I disorder

Criteria

Only subjects participating in another specific clinical trial will be invited to participate in this study.

The inclusion/exclusion criteria for this observational study are based on the individual inclusion/exclusion criteria for each of the studies and can be found for each of the studies on this website.

The specific studies and their numbers are found on their individual ClinicalTrials.gov site.

INCLUSION CRITERIA:

Bipolar I, depressed Major depression Meeting all criteria to sign the informed consent for each study included in this study who currently have a major depression (unipolar or bipolarI)

EXCLUSION CRITERIA:

Medically unstable (based on opinion of sponsor and PI Unable to meet the criteria to conform to the Rush University informed consent process

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683214

Sponsors and Collaborators

Rush University Medical Center

Investigators


Principal Investigator:	John M Zajecka, MD	RushUMC ; Rush University Medical center

More Information


Responsible Party:	John Zajecka, Associate Professor of Psychiatry, Rush University Medical Center
ClinicalTrials.gov Identifier:	NCT01683214 History of Changes
Other Study ID Numbers:	11122902
Study First Received:	September 7, 2012
Last Updated:	April 4, 2016
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Depression Depressive Disorder Depressive Disorder, Major	Behavioral Symptoms Mood Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2016

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