Brain Network Activation Analysis to Diagnose/Assess Treatment of Unipolar Major Depression and Bipolar I Depression

Depression Clinical Trial

— BNA-Mood  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01683214
• Other study ID #: 11122902
• Status: Terminated
• Start date: August 2012
• Est. completion date: August 21, 2015

Study information

• Verified date: November 2020
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: August 21, 2015
• Est. primary completion date: August 21, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of changes in BNA with changes in mood symptoms	This is an observational study, so no other outcomes are measured	Beginning of study to end of study