Clinical trial NCT01579942: Potential Use Of Brain Network Activation Analysis to Diagnose Major Depression
Official title: Potential Use Of Brain Network Activation Analysis Using Evoked Response Potentials to Diagnose Major Depression and Assess Response to Antidepressant Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Major Depressive Disorder
Keywords: EEG
Biomarker
Major Depressive Disorder
Healthy Control
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: ElMindA Ltd
First posted: 2012-04-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Brain Network Analysis group patterns
timeFrame: 8 weeks
Secondary outcomes:
measure: Identify possible predictors of treatment response
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Depression Clinical and Research Program
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Cristina Cusin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Ottavio Vitolo, MD
role: PRINCIPAL_INVESTIGATOR
References: