Potential Use Of Brain Network Activation Analysis to Diagnose Major Depression

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
ElMindA Ltd
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01579942
First received: April 11, 2012
Last updated: July 16, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Brain Network Analysis group patterns [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Cristina Cusin, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01579942     History of Changes
Other Study ID Numbers: 2011P000200
Study First Received: April 11, 2012
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014