Prediction of SSRI Treatment in Major Depression.

• Conditions: Major Depression
• Interventions: Device: SIEMENS PRISMA MRI

• Registration Number: NCT03670823
• Lead Sponsor: ElMindA Ltd

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.

Study Timeline

• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-14
• Study Start: 2019-03-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-07
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients 18-65 years old
2. Male and female
3. Ability to comprehend and sign informed consent
4. DSM-5 diagnosis with MINI 7.0.2 (healthy subjects need to be ruled out)

Inclusion Criteria for patients with depression:

1. DSM-5 diagnosis
2. 0-2 failed treatments
3. Patients which will start SSRI treatment

Exclusion Criteria

1. unconsciousness
2. Pregnancy or nursing
3. Cardiovascular instability
4. Metabolic instability (water, electrolytes, sugar)
5. Fever or evidence of microbiological pollutant
6. Deafness or blindness
7. Schizophrenia
8. Addiction disorders
9. Eating disorders
10. Bi-polar disorder
11. Cognitive deficits
12. Start a new psychotherapy during the research
13. Unable to enter the MRI scanner

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy subjects	SIEMENS PRISMA MRI	50 healthy subjects for a control group
Patients with Major Depression	SIEMENS PRISMA MRI	50 patients with major depression for a research group

Primary Outcome Measures

Name	Time	Method
EEG responses to cognitive tasks in combination with the Eye-tracker Device.	2 years	Categorize patients into subgroups according to combined measures of EEG and Eye

Secondary Outcome Measures

Name	Time	Method
Examine correlations between the different methods	2 years	Examine correlations between the different methods EEG, Eye-tracking and fMRI
Eye-tracking tasks	2 years	Categorize patients into subgroups according to similar patterns of eye movements.
Examine MRI structural changes	2 years	Compare structural changes between the groups (patients with depression, healthy subjects).
EEG brain activation to cognitive tasks	2 years	Categorize patients into subgroups according to similar brain activity
Resting state connectivity analysis	2 years	Examine the difference in resting state connectivity between the groups.
Cognitive scores on CANTAB (computerized cognitive assessments)	2 years	Examine the difference in responses to different cognitive exams between the groups

Trial Locations

Locations (1)

Sheba Medical CENTER; 🇮🇱 Ramat Gan, Israel