Overview

This trial is active, not recruiting.

Condition major depressive disorder
Sponsor Massachusetts General Hospital
Collaborator ElMindA Ltd
Start date April 2012
End date April 2015
Trial size 70 participants
Trial identifier NCT01579942, 2011P000200

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Patients who have Major Depressive Disorder and are taking a Selective Serotonin Re-uptake Inhibitor (SSRI) as part of another study at our clinic.
Patient with no history of significant mental health problems.

Primary Outcomes

Measure
Brain Network Analysis group patterns
time frame: 8 weeks

Secondary Outcomes

Measure
Identify possible predictors of treatment response
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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.

Additional Information

Official title Potential Use Of Brain Network Activation Analysis Using Evoked Response Potentials to Diagnose Major Depression and Assess Response to Antidepressant Treatment
Principal investigator Cristina Cusin, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.