Potential Use Of Brain Network Activation Analysis to Diagnose Major Depression

NCT ID: NCT01579942

Last Updated: 2017-03-06

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30

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.

Conditions

Major Depressive Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Healthy Controls

Patient with no history of significant mental health problems.

No interventions assigned to this group

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

• 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

• • 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ElMindA Ltd

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cristina Cusin, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristina Cusin, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Ottavio Vitolo, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Depression Clinical and Research Program

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2011P000200

Identifier Type: -

Identifier Source: org_study_id