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

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ClinicalTrials.gov Identifier: NCT01683214
Recruitment Status : Enrolling by invitation
First Posted : September 11, 2012
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
John Zajecka, Rush University Medical Center

Study Description
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Brief Summary:
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 or disease
Depression

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
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
Study Start Date : August 2012
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

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U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Correlation of changes in BNA with changes in mood symptoms [ Time Frame: Beginning of study to end of study ]
    This is an observational study, so no other outcomes are measured


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683214


Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: John M Zajecka, MD RushUMC ; Rush University Medical center
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

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