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Clinical Trials/NCT03670823
NCT03670823
Unknown
Not Applicable

A Combination of Innovative Technologies: EEG, Eye Tracking Device and fMRI in Order to Predict the Success of SSRI Treatment in Patients With Major Depression.

ElMindA Ltd1 site in 1 country100 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depression
Sponsor
ElMindA Ltd
Enrollment
100
Locations
1
Primary Endpoint
EEG responses to cognitive tasks in combination with the Eye-tracker Device.
Last Updated
6 years ago

Overview

Brief Summary

This project will combine the data collected from EEG, Eye tracking, structural and functional MRI scans and neuropsychological performance from patients with major depression receiving SSRI treatment. The purpose of this research is to predict the success of the SSRI treatment and to categorize patients into sub-groups according to similar patterns of brain activation to personalize treatment.

Detailed Description

Major depression is a mood disorder affecting 350 million people worldwide. The disorder is characterized by depressed mood, anhedonia, decreased quality of life, deficits in cognitive functions and even suicide thoughts. Treatment of depression is often a long process and includes taking different types and quantities of medications. Therefore, there is a need to predict the success of the SSRI treatment. Our research will examine the outcomes of the combined technologies: BNA (EEG), Eye-tracker, structural and functional MRI scans and neuropsychology tasks in patients with depression while receiving SSRI treatment. The purpose of the research is to track biomarkers and other measures, which will allow predicting the SSRI treatment's success within 4 weeks instead of 8 weeks. In addition, the investigators will attempt to categorize patients into different subgroups according to their brain activation and eye movements. This division into subgroups may contribute to the understanding of the mechanisms that account for the responsiveness to SSRI treatment and to the possibility of targeting patients with depression towards a particular treatment. From this research, the investigators aim to personalize the treatment of depression, make it more efficient and reduce the amount of time for the patient to reach an optimal responsiveness.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
October 1, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
ElMindA Ltd
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients 18-65 years old
  • Male and female
  • Ability to comprehend and sign informed consent
  • DSM-5 diagnosis with MINI 7.0.2 (healthy subjects need to be ruled out)
  • Inclusion Criteria for patients with depression:
  • DSM-5 diagnosis
  • 0-2 failed treatments
  • Patients which will start SSRI treatment

Exclusion Criteria

  • unconsciousness
  • Pregnancy or nursing
  • Cardiovascular instability
  • Metabolic instability (water, electrolytes, sugar)
  • Fever or evidence of microbiological pollutant
  • Deafness or blindness
  • Schizophrenia
  • Addiction disorders
  • Eating disorders
  • Bi-polar disorder

Outcomes

Primary Outcomes

EEG responses to cognitive tasks in combination with the Eye-tracker Device.

Time Frame: 2 years

Categorize patients into subgroups according to combined measures of EEG and Eye

Secondary Outcomes

  • Eye-tracking tasks(2 years)
  • Examine MRI structural changes(2 years)
  • Examine correlations between the different methods(2 years)
  • EEG brain activation to cognitive tasks(2 years)
  • Resting state connectivity analysis(2 years)
  • Cognitive scores on CANTAB (computerized cognitive assessments)(2 years)

Study Sites (1)

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