Prediction of SSRI Treatment in Major Depression.

ElMindA

Status: Unknown

Conditions: Major Depression

Treatments: Device: SIEMENS PRISMA MRI

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03670823

ELM-55 5323-18-SMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Healthy subjects

Description:

50 healthy subjects for a control group

Treatment:

Device: SIEMENS PRISMA MRI

Patients with Major Depression

Description:

50 patients with major depression for a research group

Treatment:

Device: SIEMENS PRISMA MRI