NCT03670823

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

June 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1.6 years

First QC Date

September 12, 2018

Last Update Submit

June 6, 2019

Conditions

Major Depression

Keywords

Major DepressionEEGEye TrackerfMRIMRIResting State ConnectivityCognition

Outcome Measures

Primary Outcomes (1)

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

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

    2 years

Secondary Outcomes (6)

  • Resting state connectivity analysis

    2 years

  • Examine correlations between the different methods

    2 years

  • EEG brain activation to cognitive tasks

    2 years

  • Eye-tracking tasks

    2 years

  • Examine MRI structural changes

    2 years

  • +1 more secondary outcomes

Study Arms (2)

Healthy subjects

50 healthy subjects for a control group

Device: SIEMENS PRISMA MRI

Patients with Major Depression

50 patients with major depression for a research group

Device: SIEMENS PRISMA MRI

Interventions

SIEMENS PRISMA MRIDEVICE

Collect data on brain activation from different methods

Also known as: BNA (EEG) Technology, Eyetracking device
Healthy subjectsPatients with Major Depression

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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)
  • DSM-5 diagnosis
  • failed treatments
  • Patients which will start SSRI treatment

You may not qualify if:

  • 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
  • Cognitive deficits
  • Start a new psychotherapy during the research
  • Unable to enter the MRI scanner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical CENTER

Ramat Gan, 52621, Israel

RECRUITING

Related Publications (4)

  • Drysdale AT, Grosenick L, Downar J, Dunlop K, Mansouri F, Meng Y, Fetcho RN, Zebley B, Oathes DJ, Etkin A, Schatzberg AF, Sudheimer K, Keller J, Mayberg HS, Gunning FM, Alexopoulos GS, Fox MD, Pascual-Leone A, Voss HU, Casey BJ, Dubin MJ, Liston C. Resting-state connectivity biomarkers define neurophysiological subtypes of depression. Nat Med. 2017 Jan;23(1):28-38. doi: 10.1038/nm.4246. Epub 2016 Dec 5.

    PMID: 27918562BACKGROUND

  • Ogawa T, Sekino H, Uzura M, Sakamoto T, Taguchi Y, Yamaguchi Y, Hayashi T, Yamanaka I, Oohama N, Imaki S. Comparative study of magnetic resonance and CT scan imaging in cases of severe head injury. Acta Neurochir Suppl (Wien). 1992;55:8-10. doi: 10.1007/978-3-7091-9233-7_3.

    PMID: 1414552BACKGROUND

  • Raichle ME, Snyder AZ. A default mode of brain function: a brief history of an evolving idea. Neuroimage. 2007 Oct 1;37(4):1083-90; discussion 1097-9. doi: 10.1016/j.neuroimage.2007.02.041. Epub 2007 Mar 6.

    PMID: 17719799BACKGROUND

  • Rohden AI, Benchaya MC, Camargo RS, Moreira TC, Barros HMT, Ferigolo M. Dropout Prevalence and Associated Factors in Randomized Clinical Trials of Adolescents Treated for Depression: Systematic Review and Meta-analysis. Clin Ther. 2017 May;39(5):971-992.e4. doi: 10.1016/j.clinthera.2017.03.017. Epub 2017 May 2.

    PMID: 28476404BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Central Study Contacts

Revital Amiaz

CONTACT

+972505250590Revital.Amiaz@sheba.health.gov.il

Liran Korine

CONTACT

+972507453300liran@elminda.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 14, 2018

Study Start

March 1, 2019

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

June 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)