Prediction of SSRI Treatment in Major Depression.

June 6, 2019 updated by: ElMindA Ltd

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study population will include 2 groups of subjects: healthy subjects and patients with major depression

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy subjects
50 healthy subjects for a control group
Device: SIEMENS PRISMA MRI
Collect data on brain activation from different methods
Other Names:
  • BNA (EEG) Technology, Eyetracking device
Patients with Major Depression
50 patients with major depression for a research group
Device: SIEMENS PRISMA MRI
Collect data on brain activation from different methods
Other Names:
  • BNA (EEG) Technology, Eyetracking device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resting state connectivity analysis
Time Frame: 2 years
Examine the difference in resting state connectivity between the groups.
2 years
Examine correlations between the different methods
Time Frame: 2 years
Examine correlations between the different methods EEG, Eye-tracking and fMRI
2 years
EEG brain activation to cognitive tasks
Time Frame: 2 years
Categorize patients into subgroups according to similar brain activity
2 years
Eye-tracking tasks
Time Frame: 2 years
Categorize patients into subgroups according to similar patterns of eye movements.
2 years
Examine MRI structural changes
Time Frame: 2 years
Compare structural changes between the groups (patients with depression, healthy subjects).
2 years
Cognitive scores on CANTAB (computerized cognitive assessments)
Time Frame: 2 years
Examine the difference in responses to different cognitive exams between the groups
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ElMindA Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sheba Medical Center
Hebrew University of Jerusalem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ELM-55 5323-18-SMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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