Potential Use Of Brain Network Activation Analysis to Diagnose Major Depression

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01579942
• Other study ID #: 2011P000200
• Status: Terminated
• Phase: N/A
• First received: April 11, 2012
• Last updated: March 2, 2017
• Start date: April 2012

Study information

• Verified date: March 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Locations

Country	Name	City	State
United States	Depression Clinical and Research Program	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	ElMindA Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain Network Analysis group patterns	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].	8 weeks
Secondary	Identify possible predictors of treatment response	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.	8 weeks