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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01683214
Recruitment Status : Unknown
Verified March 2018 by John Zajecka, Rush University Medical Center.
Recruitment status was:  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

Tracking Information
First Submitted Date September 7, 2012
First Posted Date September 11, 2012
Last Update Posted Date March 20, 2018
Study Start Date August 2012
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 5, 2014)
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
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Brain Network Activation Analysis to Diagnose/Assess Treatment of Unipolar Major Depression and Bipolar I Depression
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
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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Depression
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 7, 2012)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01683214
Other Study ID Numbers 11122902
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party John Zajecka, Rush University Medical Center
Study Sponsor Rush University Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: John M Zajecka, MD RushUMC ; Rush University Medical center
PRS Account Rush University Medical Center
Verification Date March 2018