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Trial record 6 of 2592 for:    depression AND Major Depression | "Depression"

Prediction of SSRI Treatment in Major Depression.

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ClinicalTrials.gov Identifier: NCT03670823
Recruitment Status : Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Collaborators:
Sheba Medical Center
Hebrew University of Jerusalem
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Major Depression Device: SIEMENS PRISMA MRI

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 : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: 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.
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy subjects
50 healthy subjects for a control group
Device: SIEMENS PRISMA MRI
Collect data on brain activation from different methods
Other Name: 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 Name: BNA (EEG) Technology, Eyetracking device




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Resting state connectivity analysis [ Time Frame: 2 years ]
    Examine the difference in resting state connectivity between the groups.

  2. Examine correlations between the different methods [ Time Frame: 2 years ]
    Examine correlations between the different methods EEG, Eye-tracking and fMRI

  3. EEG brain activation to cognitive tasks [ Time Frame: 2 years ]
    Categorize patients into subgroups according to similar brain activity

  4. Eye-tracking tasks [ Time Frame: 2 years ]
    Categorize patients into subgroups according to similar patterns of eye movements.

  5. Examine MRI structural changes [ Time Frame: 2 years ]
    Compare structural changes between the groups (patients with depression, healthy subjects).

  6. Cognitive scores on CANTAB (computerized cognitive assessments) [ Time Frame: 2 years ]
    Examine the difference in responses to different cognitive exams between the groups



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Study population will include 2 groups of subjects: healthy subjects and patients with major depression
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670823


Contacts
Contact: Revital Amiaz +972505250590 Revital.Amiaz@sheba.health.gov.il
Contact: Liran Korine +972507453300 liran@elminda.com

Sponsors and Collaborators
ElMindA Ltd
Sheba Medical Center
Hebrew University of Jerusalem

Publications:
Responsible Party: ElMindA Ltd
ClinicalTrials.gov Identifier: NCT03670823     History of Changes
Other Study ID Numbers: 5323-18-SMC
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by ElMindA Ltd:
Major Depression
EEG
Eye Tracker
fMRI
MRI
Resting State Connectivity
Cognition

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders