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Clinical Trials/NCT01579942
NCT01579942
Terminated
Not Applicable

Potential Use Of Brain Network Activation Analysis Using Evoked Response Potentials to Diagnose Major Depression and Assess Response to Antidepressant Treatment

Massachusetts General Hospital1 site in 1 country70 target enrollmentApril 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
Massachusetts General Hospital
Enrollment
70
Locations
1
Primary Endpoint
Brain Network Analysis group patterns
Status
Terminated
Last Updated
9 years ago

Overview

Brief Summary

The investigators are doing this study to find out if they can use electroencephalographic (EEG) recordings, which measure brain waves, to predict response to antidepressant treatments, as well as to distinguish patients who have depression from those who do not. In particular the investigators want to test the usefulness of a new type of analysis of 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.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
TBD
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cristina Cusin, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • • Male and female outpatients, aged 18-55 years
  • Subjects meeting full criteria for the diagnosis of current Major Depressive Disorder (MDD) without psychotic features, as determined by clinical evaluation and Mood Module of structured diagnostic interview (SCID), completed by the study clinician.
  • HAM-D17 score of 14 or higher
  • Able to provide informed consent
  • Right handed, normal (corrected) vision and normal hearing

Exclusion Criteria

  • • Other primary diagnoses including major depressive disorder with psychotic features, bipolar disorder, schizoaffective disorder, schizophrenia, dementia, attention deficit hyperactivity disorder (ADHD).
  • Substance use disorder (abuse or dependence with active use within the last 6 months).
  • Significant sensory deficits such as deafness or blindness.
  • Severe or unstable medical illness, including history of closed head injury resulting in loss of consciousness, seizure disorder; history of neurological disorders.
  • Pregnant or nursing females who are not using an accepted method of contraception (birth control pill, IUD, combination of barrier methods)
  • Clinically significant abnormal laboratory values or electrocardiogram For Healthy Controls
  • Inclusion Criteria:
  • Males and females, aged 18-55 years
  • Subjects who do not meet full criteria for any of the major psychiatric diagnosis including MDD, bipolar disorder, schizophrenia, substance abuse/dependence, attention deficit hyperactivity disorder (ADHD), as determined by clinical evaluation and structured diagnostic interview, completed by the study clinician.
  • Right handed, normal (corrected) vision and normal hearing

Outcomes

Primary Outcomes

Brain Network Analysis group patterns

Time Frame: 8 weeks

The investogators will make a comparison of Functional networks of brain activity (BNA™) in subjects with MDD and healthy individuals measured using analysis of EEG Event Related Potential (ERP) data \[ Time Frame: Baseline, 1 week after the first dose of antidepressant treatment, end of the treatment phase\].

Secondary Outcomes

  • Identify possible predictors of treatment response(8 weeks)

Study Sites (1)

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