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Potential Use Of Brain Network Activation Analysis to Diagnose Major Depression

This study has been terminated.
(The study was ultimately not funded by the sponsor. No subjects were enrolled.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01579942
First Posted: April 18, 2012
Last Update Posted: March 6, 2017
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.
Collaborator:
ElMindA Ltd
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital
  Purpose
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.

Condition
Major Depressive Disorder

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Potential Use Of Brain Network Activation Analysis Using Evoked Response Potentials to Diagnose Major Depression and Assess Response to Antidepressant Treatment

Further study details as provided by Cristina Cusin, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Identify possible predictors of treatment response [ Time Frame: 8 weeks ]

    The investigators will examine the agreement between clinical diagnoses and the change of Brain Network Activation (BNA™)Scores in MDD subjects and healthy controls.

    Subjects will undergo clinical diagnostic interviews and a comprehensive neuropsychological and cognitive assessment, and then complete 1 EEG scan of approximately 1 hour. The results of the BNA will be compared to the results of the clinical diagnostic interviews and tests.



Estimated Enrollment: 70
Study Start Date: April 2012
Groups/Cohorts
Patients with Major Depressive Disorder
Patients who have Major Depressive Disorder and are taking a Selective Serotonin Re-uptake Inhibitor (SSRI) as part of another study at our clinic.
Healthy Controls
Patient with no history of significant mental health problems.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

For Patients with Major Depressive Disorder

• 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.

For Healthy controls

  • 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, as determined by clinical evaluation and structured diagnostic interview, completed by the study clinician.
Criteria

For Patients with Major Depressive Disorder

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

Exclusion Criteria:

  • Any current primary psychiatric, or medical condition determined to be clinically significant.
  • Current use of psychotropics or any medication with clinically significant central nervous system effects.
  Contacts and Locations
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): NCT01579942


Locations
United States, Massachusetts
Depression Clinical and Research Program
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
ElMindA Ltd
Investigators
Principal Investigator: Cristina Cusin, MD Massachusetts General Hospital
Principal Investigator: Ottavio Vitolo, MD Massachusetts General Hospital
  More Information

Responsible Party: Cristina Cusin, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01579942     History of Changes
Other Study ID Numbers: 2011P000200
First Submitted: April 11, 2012
First Posted: April 18, 2012
Last Update Posted: March 6, 2017
Last Verified: March 2017

Keywords provided by Cristina Cusin, MD, Massachusetts General Hospital:
EEG
Biomarker
Major Depressive Disorder
Healthy Control

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